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6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP Adverse Event — Injury (MDR 2182269-2008-00057)

6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP Adverse Event — Injury (MDR 2182269-2008-00057) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP; Generic name: ANGIO-SEAL VIP; Manufacturer: ST. JUDE MEDICAL.

Device6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
Generic nameANGIO-SEAL VIP
ManufacturerST. JUDE MEDICAL
Report number2182269-2008-00057
Event typeInjury
Product problemN
Date received2008-02-21
Report sourceHealth Professional, User facility, Company representation
NarrativeIT WAS REPORTED A 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERIOTOMY. BLEEDING CONTINUED AND A FEMOSTOP WAS USED TO CONTROL THE BLEEDING. HEMOSTASIS WAS ACHIEVED. FOUR DAYS LATER THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF A COLD FOOT AND DIMINISHED PULSES. AN INTERVENTIONAL RADIOLOGIST PERFORMED AN ANGIOGRAM, ULTRASOUND, AND ANGIOPLASTY OF THE OCCLUDED SITE. PULSES
SourceopenFDA MAUDE (device adverse events)

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