BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 6663501 · Received June 23, 2017

    Report

    Report Number
    2024168-2017-05306
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    May 24, 2017
    Report Date
    August 22, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - 323022/1-1. EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED KINK AND PEELED POLYMER WERE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES TO BE RELATED TO THE PATIENT ANATOMICAL CONDITIONS AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED FIRST MARGINAL ARTERY THAT WAS (B)(4) STENOSED. A ROTABLATOR WAS USED IN THE HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. A NON-ABBOTT GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION. A WHISPER GUIDE WIRE WAS ADVANCE TO BE USED AS A BUDDY WIRE BUT IT ONLY CROSSED TO THE MIDDLE OF THE LESION. THE WHISPER GUIDE WIRE WAS REMOVED AND ONCE OUTSIDE THE ANATOMY IT WAS NOTED THAT THE TIP WAS KINKED 1 CM PROXIMAL TO THE TIP BALL AND THE POLYMER JACKET WAS PEELED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446140 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 6110771

    Patients

    Seq Age Sex Outcome Treatment
    1