BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2880065 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08163
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE STATES: IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. DO NOT PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. 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, AN UNSPECIFIED BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TOWARD A HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS CIRCUMFLEX CORONARY ARTERY, BUT WAS UNABLE TO CROSS THE LESION DUE TO ANATOMICAL CONDITIONS. DURING THE ATTEMPT TO CROSS, FORCE WAS REPORTEDLY APPLIED AGAINST THE RESISTANCE. AFTER WITHDRAWAL FROM THE ANATOMY, WITHOUT RESISTANCE FELT, IT WAS NOTED THAT THE GUIDE WIRE TIP COILS HAD UNRAVELED, HOWEVER, THE TOTAL LENGTH OF THE GUIDE WIRE DID NOT APPEAR TO BE LONGER THAN SPECIFIED. THE BMW WAS WITHDRAWN FROM THE ANATOMY AND A NEW BMW GUIDE WIRE WAS USED IN COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. WHILE A DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED, THE DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1