BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCA - EX ATHEROCATHETER

    MDR report key: 4379 · Received January 19, 1993

    Report

    Report Number
    4379
    Event Type
    Malfunction
    Date Received
    January 19, 1993
    Date of Event
    October 15, 1992
    Report Date
    January 19, 1993
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING ARTHRECTOMY PROCEDURE THE "DISTAL RADIAL OPAQUE PORTION OF THE WIRE REMAINED IN THE DISTAL RIGHT CORONARY ARTERY. ATTEMPTS TO RETREIVE IT WERE NOT SUCCESSFUL". MEDICAL FINDINGS FROM THE PROCEDURE WERE NOT AFFECTED. MFG. REP NOTIFIED AND CAME TO VIEW THE SCA EX ATHERO CATH AND PHOTOGRAPHS WERE TAKEN OF THE PRODUCTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.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 SCA - EX ATHEROCATHETER MCX DEVICES FOR VASCULAR INTERVENTION EX70-09 122371

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other