BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHOLEY HI-TORQUE STANDARD GUIDE WIRE

    MDR report key: 2895009 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00021
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K083706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. DATE OF EVENT - ESTIMATED. THE ADDITIONAL WHOLEY GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    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 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 RADIAL ACCESS HEART CATHETER PROCEDURE WITH TORTUOUS ANATOMY, TWO WHOLEY GUIDE WIRES WERE USED TO TRANSVERSE THE DIFFICULT ANATOMY. REPORTEDLY, THE WIRES WERE SEPARATED AT A TRANSITION POINT; HOWEVER, DID NOT COME ENTIRELY UNCOILED SO THERE WAS NOT A COMPLETE SEPARATION. THE WIRES WERE REMOVED FROM THE PATIENT WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3307 WHOLEY HI-TORQUE STANDARD GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2080801

    Patients

    Seq Age Sex Outcome Treatment
    1