BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1884056 · Received October 20, 2010

    Report

    Report Number
    2182269-2010-00187
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ANCHOR, COLLAGEN FRAGMENT, AND SUTURE SEGMENT, CONSISTENT WITH COMPONENTS USED IN THE ANGIO-SEAL DEVICE, WERE VISUALLY INSPECTED. THE ANCHOR AND COLLAGEN FRAGMENT WERE SECURED BY THE INTACT SUTURE LOOP. THE RUNNING SUTURE WAS APPROXIMATELY 0.9" IN LENGTH; THE SUTURE PROXIMAL END WAS CONSISTENT WITH CUTTING. GOUGES AND SCRATCHES WERE NOTED ON THE LEADING LEG OF THE ANCHOR, CONSISTENT WITH SURGICAL REMOVAL AS STATED IN THE COMPLAINT DESCRIPTION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT, AS SUPPORTED BY THE MANUFACTURING TRAVELER AND THE PRODUCT ANALYSIS. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES IF THE COLLAGEN PROTRUDES FROM THE SKIN AFTER TAMPING HAS BEEN COMPLETED, ATTEMPT TO PUSH THE COLLAGEN UNDER THE SKIN USING THE TAMPER TUBE OR A STERILE HEMOSTAT. DO NOT APPLY VIGOROUS TAMPING AS THIS MAY RESULT IN ANCHOR FRACTURE. DO NOT CUT OFF THE EXCESS COLLAGEN, AS THE SUTURE WOVEN THROUGH THE COLLAGEN MAY BE CUT AND THE INTEGRITY OF THE ANCHOR/COLLAGEN SANDWICH COULD BE COMPROMISED. THE IFU CAUTIONS THAT AN AV FISTULA OR PSEUDOANEURYSM ARE POSSIBLE RISKS OR SITUATIONS ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE TO CLOSE THE RIGHT COMMON FEMORAL ARTERIOTOMY. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED, WHICH REVEALED NO TORTUOSITY AND NO PERIPHERAL VASCULAR DISEASE. IT WAS REPORTED THAT THE ANGLE OF PUNCTURE WAS ALMOST VERTICAL TO THE ARTERY DUE TO THE PT'S THICK SUBCUTANEOUS TISSUE. DURING THE PROCEDURE, THE COLLAGEN COULD NOT BE FULLY COMPRESSED BELOW THE SKIN BECAUSE OF THICK SUBCUTANEOUS TISSUE. THE PHYSICIAN TAMPED THE COLLAGEN BELOW THE SKIN AND HEMOSTASIS WAS ACHIEVED AND THE PT WAS ON BED REST FOR 5 HOURS. TWO DAYS LATER, THE PT COMPLAINED OF PAIN AND SWELLING. AN ULTRASOUND REVEALED A PSEUDOANEURYSM, IN WHICH, AN ALLEGED ANGIO-SEAL COMPONENT WAS INCLUDED. THE PT UNDERWENT SURGERY AND VESSEL REPAIR WAS SUCCESSFULLY PERFORMED. AN ALLEGED ANGIO-SEAL ANCHOR WAS REMOVED. THE PT WAS REPORTEDLY RECOVERING AND WAS DISCHARGED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 3095061

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R CLOPIDOGREL - 75MG| ASPIRIN - 100 MG