BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1250683 · Received December 2, 2008

    Report

    Report Number
    2182269-2008-00348
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 3, 2008
    Report Date
    December 2, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANOCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, TO NOT RE-INSERT THE DEVICE. RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO BE DEPOSITED IN THE ARTERY. THE IFU ALSO STATE FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DIAGNOSTIC RIGHT AN LEFT HEART CATHETERIZATION, THE PHYSICIAN SEALED THE RIGHT COMMON FEMORAL ARTERY (CFA) WITH A 6F ANGIO-SEAL VIP. A FEMORAL ANGIOGRAM REVEALED NO SIGNIFICANT DISEASE WITH GOOD SHEATH PLACEMENT AND ADEQUATE VESSEL SIZE. HEMOSTASIS WAS OBTAINED AND THE PATIENT WAS SENT TO THE HOLDING AREA WHERE THE VENOUS SHEATH WAS REMOVED. APPROXIMATELY 45 MINUTES LATER, THE PATIENT BEGAN COMPLAINING OF LIGHT LEG PAIN AND AN ARTERIAL LOWER EXTREMITY DUPLEX SCAN WAS PERFORMED. THE DOPPLER REVEALED AN OCCLUSION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS THEN SENT TO A CONTRALATERAL ACCESS ANGIOGRAM OF THE RIGHT LOWER EXTREMITY. THE PHYSICIAN CONFIRMED THAT ANGIOGRAPHICALLY THAT THERE WAS A PROXIMAL OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY AND THAT SURGICAL THROMBECTOMY WAS REQUIRED. THE PHYSICIAN SURGICALLY ISOLATED THE INSERTION OF THE ANGIO-SEAL AND REMOVED THE "PLUG" THAT HE FOUND INTRALUMINAL AND THEN REMOVED REMAINING THROMBUS WITH A FOGARTY BALLOON CATHETER. THE ARTERIOTOMY WAS THEN CLOSED WITH SUTURE AND THE CLAMPS WERE REMOVED RESTORING FLOW. THE PATIENT TOLERATED THE PROCEDURE AND RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention