BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PROGRESS 40 GUIDE WIRE

    MDR report key: 2955798 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00792
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: DILATATION CATHETER: VOYAGER RX, SAPPHIRE; GUIDE CATHETER: HEARTRAIL JL3.5. 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 NONCONFORMANCES ASSOCIATED WITH THIS 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 THE PROCEDURE IN THE MILDLY TORTUOUS/HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY FOR TREATMENT OF A 99% STENOSIS, AN ATTEMPT WAS MADE TO ADVANCE A .014 HT PROGRESS 40 GUIDE WIRE; HOWEVER, THE TIP OF THE GUIDE WIRE BECAME STUCK APPROXIMATELY HALF WAY INTO THE LESION. NO FORCE WAS APPLIED TO THE GUIDE WIRE. DURING WITHDRAWAL OF THE GUIDE WIRE, SLIGHT RESISTANCE WAS FELT, SLIGHT FORCE WAS APPLIED, AND THE GUIDE WIRE WAS WITHDRAWN FROM THE ANATOMY SUCCESSFULLY. OUTSIDE OF THE ANATOMY, THE GUIDE WIRE TIP WAS EXAMINED AND FOUND TO BE SEVERELY BENT 1 CM PROXIMAL TO THE DISTAL END. A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND CROSSED THE LESION SUCCESSFULLY. PRE-DILATATION WAS PERFORMED AND A XIENCE PRIME 2.5X23 STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59831 HI-TORQUE PROGRESS 40 GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1050602

    Patients

    Seq Age Sex Outcome Treatment
    1