BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT VASCULAR DEVICES

    MDR report key: 547755 · Received September 23, 2004

    Report

    Report Number
    547755
    Event Type
    Other
    Date Received
    September 23, 2004
    Date of Event
    August 27, 2004
    Report Date
    September 23, 2004
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A CARDIAC CATHETERIZATION. THE CATHETER WENT WELL UNTIL MD, MEDICAL DOCTOR, WAS UNABLE TO REMOVE THE PERCLOSE DEVICE. TRIED TO CHANGE WIRE OVER THE DEVICE, THE DEVICE WOULD NOT LOCK. ATTEMPTED TO PUSH OR ROTATE DEVICE NOTHING WORKED. VASCULAR SURGERY WAS CONSULTED AND THE PATIENT TAKEN TO THE OR, OPERATING ROOM. THERE APPEARED TO BE TISSUE BLOCKING THE FOOT OF THE DEVICE. ONCE THE TISSUE WAS REMOVED, THE DEVICE FUNCTIONED. THE DEVICE WAS REMOVED IN THE OR AND THE ARTERY REPAIRED WITH A BOVINE PERICARDIAL PATCH. POST-OPERATIVELY THE PATIENT DID WELL AND WAS DISCHARGED HOME. A POST OPERATIVE EXAM NOTED THE GROIN WOUND IS HEALING NICELY WITHOUT EVIDENCE OF ERYTHEMA OR INFECTION. THERE IS A +2 FEMORAL PULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR DEVICES PERCLOSE PROGLIDE MGB ABBOTT VASCULAR DEVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR