BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 3031660 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01932
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    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. IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A DE NOVO, CONCENTRIC LESION IN THE DISTAL LEFT CIRCUMFLEX WITH MODERATE TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS, A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED THROUGH THE LESION. A 2.75X13 NON-ABBOTT DILATATION CATHETER WAS ADVANCED OVER THE BMW ELITE GUIDE WIRE WITHOUT RESISTANCE. REPORTEDLY, AFTER INFLATING THE BALLOON AND WHEN ATTEMPTING TO REMOVE THE DILATATION CATHETER, RESISTANCE WAS FELT WITH THE BMW ELITE GUIDE WIRE. THE NON-ABBOTT DILATATION CATHETER, THE BMW ELITE GUIDE WIRE AND THE GUIDE CATHETER WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. A NEW BMW ELITE GUIDE WIRE WAS USED AND THE SAME NON-ABBOTT BALLOON WAS RE-ADVANCED AND INFLATED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134049 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091301

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: LACROSSE NSE 2.75X13