BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PROGRESS 80 GUIDE WIRE

    MDR report key: 4093449 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05959
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED RESISTANCE WITH A MICRO CATHETER WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT WAS REPORTED THAT THE PROGRESS 80 GUIDE WIRE WAS PULLED WITH FORCE TO RETRACT IT FROM THE CATHETER. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, HI-TORQUE PROGRESS GW, (B)(4) WARNINGS SECTION STATES: DO NOT PUSH, AUGER, WITHDRAW OR TORQUE IF THE TIP IS NOT MANEUVERABLE, OR IT BECOMES ENTRAPPED WITHIN THE VASCULATURE AND THIS DEVICE MEETS RESISTANCE. DETERMINE THE CAUSE OF RESISTANCE AND TAKE APPROPRIATE REMEDIAL ACTION AS NEEDED.

    Additional Manufacturer Narrative · 1

    (B)(4) - EXCESSIVE FORCE 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 DE NOVO LESION LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 100% STENOSED MID AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AS A NON-ABBOTT GUIDE WIRE WAS UNABLE TO CROSS, AND ATTEMPT WAS MADE TO CROSS WITH THE PROGRESS 80 GUIDE WIRE; HOWEVER, IT ADVANCED INTO A FALSE LUMEN. NO INJURY TO THE VESSEL OCCURRED DUE TO ENTERING THE FALSE LUMEN. AN ATTEMPT WAS MADE TO REMOVE THE PROGRESS 80 GUIDE WIRE FROM THE NON-ABBOTT MICROCATHETER, RESISTANCE WAS MET BETWEEN THE INNER LUMEN OF THE MICROCATHETER AND THE GUIDE WIRE. THE PROGRESS 80 GUIDE WIRE WAS PULLED WITH FORCE TO RETRACT IT FROM THE CATHETER. A NON-ABBOTT GUIDE WIRE WAS ADVANCED WHICH WAS ABLE TO CROSS THROUGH THE TRUE LUMEN. A PERFORATION WAS OBSERVED WHICH REQUIRED BALLOON INFLATIONS TO SEAL THE PERFORATION. THE PERFORATION WAS REPORTED TO HAVE OCCURRED DURING USE OF THE NON-ABBOTT GUIDE BAREWIRE; HOWEVER, WAS NOT OBSERVED UNTIL LATER IN THE CASE. IT WAS CONFIRMED THAT THE PROGRESS 80 GUIDE WIRE DID NOT CAUSE THE PERFORATION. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A NON-ABBOTT STENT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED DUE TO THE USE OF THE PROGRESS 80 GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571358 HI-TORQUE PROGRESS 80 GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2112801

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR