BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER LS GUIDE WIRE

    MDR report key: 3153105 · Received June 8, 2013

    Report

    Report Number
    2024168-2013-03557
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, 95% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. THE WHISPER LS GUIDE WIRE WAS USED IN COMBINATION WITH A MICRO-CATHETER. DURING RETRACTION OF THE GUIDE WIRE FROM THE ANATOMY, WITH NO RESISTANCE REPORTED DURING REMOVAL, THE GUIDE WIRE TIP WAS OBSERVED TO BE MISSING. THE DISTAL PORTION OF THE TIP WAS REMOVED FROM THE PATIENT INSIDE THE MICRO-CATHETER. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255983 HI-TORQUE WHISPER LS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3022871

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER: FINECROSS MICROCATHETER