BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1913762 · Received November 24, 2010

    Report

    Report Number
    2182269-2010-00225
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    November 24, 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

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THAT A PRE-PLACEMENT ARTERIAL ANGIOGRAM BE PERFORMED TO ENSURE CORRECT PLACEMENT OF THE DEVICE IN THE COMMON FEMORAL ARTERY (CFA). ANNALS OF VASC. DISEASE VOL. 3, NO. 2 2010, DR BITO ET AL.

    Description of Event or Problem · 1

    IT WAS REPORTED ACCORDING TO JOURNAL ARTICLE VOL. 3, NO. 2, 2010 OF "ANNALS OF VASCULAR DISEASE" THAT A PT HAD PERCUTANEOUS CORONARY INTERVENTION (PCI) AND AN ANGIO-SEAL WAS SELECTED FOR CLOSURE VIA THE RIGHT COMMON FEMORAL ARTERY (CFA). THE ANGIO-SEAL WAS DEPLOYED, BUT HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS APPLIED. THE BLEEDING WAS NOT ABLE TO BE CONTROLLED, SO THE PT WAS IMMEDIATELY TAKEN TO SURGERY. THE PHYSICIAN EXPOSED THE PT'S RIGHT COMMON FEMORAL ARTERY (CFA) AND FOUND THE DEVICE SUTURE TAIL AT THE PUNCTURE SITE, ANTERIOR TO THE ARTERY. THE PHYSICIAN THEN MADE A SMALL HORIZONTAL INCISION ON THE ARTERY AND FOUND CALCIFICATION IN THE INNER ARTERIAL WALL. THE ANCHOR WAS LOCATED JUST UNDER THE INCISION, AND THE PHYSICIAN REMOVED IT EASILY BY TRACTION. ADDITIONAL INFO IS NOT AVAILABLE.

    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 61 YR Hospitalization| R