BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2834297 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07219
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE KINK WAS ABLE TO BE CONFIRMED; ADDITIONALLY, THE CORE WAS NOTED TO BE SEPARATED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD CALCIFICATION. THE WHISPER GUIDE WIRE WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION. AFTER REMOVAL, IT WAS NOTED THAT THE TIP WAS BENT AND KINKED. A NON-ABBOTT GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS BEING UPGRADED BASED ON RETURNED DEVICE ANALYSIS WHICH FOUND THAT THERE WAS A CORE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 2052272

    Patients

    Seq Age Sex Outcome Treatment
    1