BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAQUET INTRODUCER

    MDR report key: 36120 · Received August 28, 1996

    Report

    Report Number
    MW4001445
    Event Type
    Injury
    Date Received
    August 28, 1996
    Date of Event
    March 7, 1996
    Report Date
    March 8, 1996
    Manufacturer
    USCI DIV. C.R. BARD, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT END OF RF UNSUCCESSFUL ABLATION, UPON REMOVAL OF RIGHT FEMORAL VENOUS SHEATH, THE SHEATH TORE. THE DISTAL END OF THE SHEATH REMAINED IN THE FEMORAL VEIN AND MIGRATED TOWARD THE ILIAC VEIN. ATTEMPTED TO RETRIEVE BY FEMORAL CUT DOWN BUT IT HAD MIGRATED TO COMMON ILIAC VEIN. BROKEN PIECE RETRIEVED UNDER FLUOROSCOPY WITH SHARING DEVICE. BLOOD LOSS 400CC. SCAR TISSUE FELT WITH INSERTION BUT NOT DIFFICULT INSERTION. 3500 UNITS WITH HEPARIN GIVEN FOR PROCEDURE (ABLATION). SCAR TISSUE FELT TO BE FROM PREVIOUS ANGIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMAQUET INTRODUCER 7 FRENCH CATHETER INTRODUCER DYB USCI DIV. C.R. BARD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention