BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2854202 · Received November 29, 2012

    Report

    Report Number
    3003681312-2012-00069
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F ANGIO-SEAL VIP LOCATOR WAS VISUALLY/DIMENSIONALLY INSPECTED. THE LOCATOR HUB HAD BEEN DAMAGED CONSISTENTLY WITH PREVIOUS LOCKING INTO THE HEMOSTASIS CAP. THE LOCATOR HAD BEEN BENT INTO A "U" SHAPE AND ALSO KINKED AT THE BLOOD INLET HOLES. NO TIP DAMAGE OR OTHER VISUAL ANOMALIES WERE NOTED. THE LOCATOR DISTAL TIP INSIDE DIAMETER MEASUREMENT WAS CONSISTENT WITH THE SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    AN ANGIO-SEAL LOCATOR/SHEATH ASSEMBLY WAS INSERTED INTO THE PT. THE PHYSICIAN FELT LIKE THE LOCATOR MADE A SMALL TEAR IN THE FEMORAL ARTERY. THE ANGIO-SEAL WAS NOT USED OT COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 3714887

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention