BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 3160029 · Received June 10, 2013

    Report

    Report Number
    2024168-2013-03634
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    July 8, 2011
    Report Date
    May 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE STATES: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PROCEDURE WAS TO PLACE A NEPHROSTOMY CATHETER IN THE KIDNEY. SEVERAL GUIDE WIRES WERE USED, INCLUDING A WHISPER GUIDE WIRE. A FEW MONTHS AFTER THE PROCEDURE, A PORTION OF THE GUIDE WIRE WAS OBSERVED SEPARATED IN THE VESSEL ON X-RAY. THE SEPARATED PORTION WAS NOT REMOVED AND REMAINS IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260416 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other