BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5 REACH DILATATION BALLOON

    MDR report key: 4231 · Received August 12, 1992

    Report

    Report Number
    4231
    Event Type
    Injury
    Date Received
    August 12, 1992
    Date of Event
    May 19, 1992
    Report Date
    June 5, 1992
    Manufacturer
    BAXTER
    Product Code
    GBA
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON MAY 19, 1992, A PATIENT WAS UNDERGOING A DILATATION PROCEDURE IN OUR CARDIAC CATHETERIZATION LABORATORY. DURING THIS PROCEDURE, IT WAS FOUND THAT THE BALLOON WOULD NOT SUFFICIENTLY INFLATE. IT WAS REMOVED FROM THE PATIENT, TESTED AND FOUND TO HAVE A PIN-HOLE RUPTURE. A SMALL DISSECTION OF THE VESSEL WAS DISCOVERED WHILE THE PATIENT WAS STILL IN CATH. LAB.; SHE SUBSEQUENTLY WAS TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT, ON HEPARININVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5 REACH DILATATION BALLOON GBA BAXTER 72-RE2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention