BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2911358 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00242
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    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 HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: (B)(4) - INDICATION FOR USE, GUIDE WIRE WAS JAILED BENEATH THE STENT. THE DEVICE WAS RETURNED FOR ANALYSIS. THE STRETCHED COILS AND SEPARATION WERE ABLE TO BE CONFIRMED. THE DIFFICULTY REMOVING THE DEVICE 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. SEM ANALYSIS SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD. IT SHOULD BE NOTED THE HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE INSTRUCTIONS FOR USE STATES: DO NOT JAIL THIS DEVICE BETWEEN THE STENT AND THE VESSEL WALL. IT MAY BECOME IMPOSSIBLE TO WITHDRAW THIS DEVICE. IF STRONG FORCE APPLIED TO THIS DEVICE, IT MAY RESULT IN DAMAGE OR SEPARATION OF THIS DEVICE. 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 INFORMATION PROVIDED, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY CALCIFIED, ECCENTRIC, 90% STENOSED, DE NOVO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE AND A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WERE DELIVERED. AFTER PRE-DILATATION WAS COMPLETED A NON-ABBOTT STENT WAS IMPLANTED USING 12 ATMOSPHERE (ATM). IT WAS NOTED THAT THE BMW ELITE WAS JAILED WITH THE STENT AND DURING ATTEMPTS TO REMOVE THE GUIDE WIRE, IT WAS NOTED THAT THE COILS STRETCHED. THE ENTIRE BMW ELITE WAS REMOVED FROM THE ANATOMY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18172 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091301

    Patients

    Seq Age Sex Outcome Treatment
    1