BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2900518 · Received January 7, 2013

    Report

    Report Number
    2024168-2013-00138
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 13, 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. DIL CATH: TAZUNA. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 DURING A PROCEDURE OF THE 99% STENOSED, DE NOVO, DISTAL RIGHT CORONARY ARTERY (RCA), THE BALANCE MIDDLEWEIGHT (BMW) ELITE WAS POSITIONED AND A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON THE GUIDE WIRE. IT WAS NOTED THAT THE BDC BECAME STUCK WITH THE COILS OF THE GUIDE WIRE. ADDITIONALLY, IT WAS NOTED THAT THE BDC WAS SUCCESSFULLY FREED FROM THE GUIDE WIRE AND WAS REMOVED FROM THE ANATOMY. THE BMW ELITE WAS REMOVED AND REPLACED WITH A NON-ABBOTT GUIDE WIRE TO COMPLETE THE PROCEDURE. 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
    7315 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091301

    Patients

    Seq Age Sex Outcome Treatment
    1