BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V. MUELLER DIV. BAXTER HEALTHCARE CORP.

    MDR report key: 9146 · Received September 16, 1994

    Report

    Report Number
    9146
    Event Type
    Injury
    Date Received
    September 16, 1994
    Date of Event
    September 2, 1994
    Report Date
    September 13, 1994
    Manufacturer
    FOGARTY ARTERIAL EMBOLECTOMY CATHETER
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING A A-V GRAFT DECLOT PROCEDURE, AN EMBOLECTOMY CATHETER SHEARED OFF 4-5 CM FROM THE TIP END. AN X-RAY WAS TAKEN, THE TIP WAS LOCATED, A SECOND INCISION WAS MADE AND THE TIP WAS REMOVED. THE VEIN WAS DAMAGED AND A PORTION OF THE VEIN HAD TO BE REMOVED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V. MUELLER DIV. BAXTER HEALTHCARE CORP. EMBOLECTOMY CATHETER DXE FOGARTY ARTERIAL EMBOLECTOMY CATHETER CV1040 4Q04L

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention