BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER LS GUIDE WIRE

    MDR report key: 3130673 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03276
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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. ONE STERILE REPRESENTATIVE SAMPLE WITH THE SAME PART AND LOT NUMBER WAS RETURNED FOR EVALUATION. THE GUIDE WIRE WAS RETURNED IN A SEALED STERILE POUCH. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS REPORTED FOR SEPARATIONS. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A LESION IN THE AORTA, THE WHISPER LS GUIDE WIRE WAS USED AND WHILE CROSSING THE SUBCLAVIAN ARTERY THE WIRE SEPARATED; IT WAS NOT SPECIFIED IF RESISTANCE WAS NOTED. THE PHYSICIAN REMOVED THE SEPARATED SEGMENT USING SNARES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232906 HI-TORQUE WHISPER LS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3022371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention