BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2882835 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08243
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STRETCHED COILS AND SEPARATION WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL ANALYSIS AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. SEM ANALYSIS REVEALED THAT THE RIBBON FAILURE MAY BE ATTRIBUTED TO TORSIONAL OVERLOAD. 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 HAS BEEN RECEIVED. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS, 70% STENOSED, PROXIMAL, DE NOVO LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE WAS ADVANCED AND CROSSED THE LESION. AS THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A BALLOON DILATATION CATHETER OVER THE GUIDE WIRE, ANGIOGRAPHY SHOWED THE GUIDE WIRE COIL WAS STRETCHED AND TIGHTLY WRAPPED AROUND THE WIRE CORE. THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY. A SECOND GUIDE WIRE WAS USED IN THE PROCEDURE WITHOUT INCIDENT. IT WAS NOTED THAT NO RESISTANCE WAS FELT DURING THE PROCEDURE. THE PATIENT FINAL OUTCOME WAS NOTED AS SATISFACTORY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2051671

    Patients

    Seq Age Sex Outcome Treatment
    1