BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 3930411 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04484
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, CIRCUMFLEX ARTERY THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) WAS USED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER MULTIPLE TIMES AND THE UNSPECIFIED STENT SYSTEM WAS UNABLE TO ADVANCE OR CROSS THE LESION. A GUIDELINER AND A WHISPER GUIDE WIRE WERE ADVANCED BUT MET ANATOMICAL RESISTANCE AND THE GUIDELINER LOST PLACEMENT IN THE VESSEL. WHEN THE WHISPER GUIDE WIRE WAS BEING MOVED/RETRACTED IT WAS NOTED THAT THE DISTAL END OF THE GUIDE WIRE DID NOT MOVE; THE GUIDE WIRE FROM APPROXIMATELY 8 CM TO THE TIP HAD SEPARATED AND REMAINED IN THE VESSEL. SEVERAL ATTEMPTS TO SNARE THE FRAGMENT WERE UNSUCCESSFUL AND THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE GUIDE WIRE ON (B)(6) 2014. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406155 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R