BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1030141 · Received April 15, 2008

    Report

    Report Number
    2182269-2008-00121
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 25, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MHRA THAT A PHYSICIAN CONTACTED THEM TO REPORT THIS EVENT. THE PHYSICIAN REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY ANGIOGRAM, AN ANGIO-SEAL WAS USED. NO PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. REPORTEDLY, THE PUNCTURE SITE, COMMON FEMORAL ARTERY, WAS FREE OF SCARRING, FIBROTIC TISSUE, AND PERIPHERAL VASCULAR DISEASE. THE PATIENT LATER EXPERIENCED SYMPTOMS OF CLAUDICATION. A DUPLEX ULTRASOUND PERFORMED 4 MONTHS AFTER THE CORONARY PROCEDURE REVEALED THAT PART OF THE ANGIO-SEAL DEVICE HAD LODGED IN THE TIBIO-PERONEAL TRUNK. THE PATIENT UNDERWENT SURGICAL INTERVENTION ONE MONTH LATER. THE POPLITEAL ARTERY WAS EXPOSED BELOW THE KNEE AND 5,000 UNITS OF HEPARIN WAS GIVEN. A LONGITUDINAL ARTERIOTOMY WAS MADE IN THE TIBIO-PERONEAL TRUNK. ALLEGEDLY, THE ANGIO-SEAL COLLAGEN PLUG WAS REMOVED WITH SECONDARY THROMBUS. THE SURGICAL FINDINGS REVEALED THAT A TONGUE OF ORGANIZED THROMBUS HAD BEEN ATTACHED ON EITHER SIDE. THE ARTERY WAS FLUSHED AND BACK BLEEDING WAS PRESENT. A LONG SAPHENOUS VEIN PATCH REPAIR WAS SUTURED WITH 6.0 SUTURE. DOPPLER SIGNALS WERE PRESENT IN ALL RUN OFF VESSELS. THE PATIENT IS RECOVERING NICELY. THE IMPLANT DATE IS MONTH SPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention