the femoral approach is still the most commonly used route for diagnostic cardiac catheterizations and percutaneous coronary interventions . at the end of the procedure the femoral artery is usually compressed manually to control bleeding until hemostasis is achieved . local vascular complications such as bleeding and hematoma are not uncommon , ranging from less than 1% to 12% . many devices have been developed to aid in the closure of the femoral arteriotomy , including the vasoseal ( datascope inc . , jude medical devices , minneapolis , mn , usa ) , the starclose clip closure system ( abbott vascular , redwood city , ca , usa ) , and the perclose ( perclose , redwood city , ca , usa ) suture - mediated closure system . in two recent meta - analyses these devices have proven their efficacy in significantly reducing time to hemostasis while simultaneously improving patient comfort . vascular closure devices should be avoided or used with caution with non - common femoral artery sheath location , small femoral artery size , bleeding diathesis , morbid obesity , inflammatory disease , uncontrolled hypertension and in the presence of significant peripheral vascular disease , especially with calcification . in an attempt to reduce local complications , inflatable compression devices such as the femostop ( radi medical system ab , uppsala , sweden ) and the safeguard ( datascope corp . , fairfield , nj , usa ) ( figure 1 ) have thus been developed for compression of the femoral artery and are now in use in some centers because they are well accepted by the nursing staff . figure 1 the safeguard 24 cm pressure assisted dressing . 
   the safeguard 24 cm pressure assisted dressing . we hereby report a clinical experience describing a significant complication occurring after safeguard use for femoral hemostasis . in this case , an extensive pressure ulcer developed in the groin of a very elderly patient in whom a safeguard had been applied overnight because of persistent oozing after diagnostic coronary angiography . a 95-year old diabetic female was referred to our catheterization laboratory for workup of percutaneous aortic valve replacement because of a severe calcified aortic stenosis and pronounced dyspnea on effort . the patient was anesthetized locally with 2% lidocaine and the femoral artery cannulation and placement of a 6 fr introducer sheath ( cordis , miami , fl , usa ) were performed by the usual technique without complications . angiography disclosed a significant stenosis of the mid tract of the right coronary artery which was treated with a 3.518 mm bare metal stent dilated at up to 20 atm , achieving a good final angiographic and clinical result . three hours after the procedure , when a check of the activating clotting time showed a value of 150 sec , the sheath was removed and manual compression was performed . after achieving hemostasis , a 24 cm safeguard pressure assisted device was positioned in the point of maximum femoral pulse and inflated with 40 ml of air , as recommended in the device package insert . no bleeding or oozing was found after manual compression or shortly after positioning the safeguard. two hours later the safeguard bulb was deflated but a persistent oozing was observed . similarly , 4 h after positioning the safeguard another deflation attempt was performed , but oozing was still present and the device was again inflated with 20 ml of air , and kept overnight . since the volume of inflated air was significantly lower than recommended , the nurse did not deflate the bulb every 2 h as suggested by the safeguard instructions . in the early morning of the following day nonetheless , a circular area of non - blanchable erythema was observed which developed into a pressure ulceration two days after ( figure 2 ) , with partial - thickness loss of dermis . the lesion was treated with frequent irrigations of saline solution , gentle manual debridement and hydrocolloid - based dressings 
 ( 3 m tegasorb , minneapolis , mn , usa ) and resolved without any need for systemic antibiotics in a week , leaving , however , a minor scar . figure 2right groin 's extensive ( 129 cm ) pressure ulcer with loss of epidermis and dermis . right groin 's extensive ( 129 cm ) pressure ulcer with loss of epidermis and dermis . the 24 cm safeguard pressure - assisted device is a disposable device with a clear polyurethane bladder and a pressure sensitive self - adhesive peel backing . a luer valve enables a syringe to be connected to the device in order to inflate the central bladder with air to provide pressure to the puncture site . adverse effects reported by the manufacturer that may result from the use of this device include hematoma , local bleeding , pseudoa naurysm and arterio - venous fistula ; all complications associated with bleeding . to date , only a single prospective , non - randomized , multicenter study has been conducted in 101 low - risk patients to evaluate the safety and effectiveness of the safeguard space . the device proved to be effective in reducing active compression time without increasing risk in patients undergoing diagnostic and interventional procedures . the case report described here highlights how such a device , despite its inherently favorable features including user friendliness for staff , may seriously harm a patient if the instructions for use are not meticulously followed . given its inherent mechanical pressure properties , it is absolutely mandatory to deflate the bulb of the device every 2 hours to allow for capillary refill in accordance with the device instructions . even if long - term harm to the patient could be avoided , thus leading to an acceptable final cosmetic result , greater harm could have been caused , possibly with potentially dire medico - legal implications ( e.g. in the case of groin skin damage in a younger woman ) . vascular access complications are amongst the most common adverse events associated with coronary angiography and intervention . a number of devices are available to aid in 
 achieving post - procedure homeostasis . information on vascular complications from access of the femoral artery , the methods of arterial closure , and post - procedural care instructions ( including avoidance of lenghty mechanical pressure with pneumatic devices ) can help physicians and nurses to provide safe and effective care to patients after cardiac catheterization .
diagnostic cardiac catheterizations are predominantly performed using the femoral artery access . 
 several devices have been developed to aid in the closure of femoral arteriotomy.safeguard is a new pneumatic compression device that has been developed for compression of the femoral artery after brief manual compression . 
 we hereby report the case of an elderly patient who underwent a percutaneous coronary intervention via the femoral artery in whom a safeguard device , left overnight because of persistent oozing , provoked an extensive pressure ulcer . 
 knowledge of this potential complication is important to minimize its occurance and provide appropriate treatment .