BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 2132832 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04317
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    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. POLYMER DAMAGE CAN OCCUR DUE TO, BUT IS NOT LIMITED TO, MANUFACTURING, INTERACTION WITH THE GUIDING CATHETER, AND/OR INTERACTION WITH A TORQUE DEVICE. IT IS POSSIBLE THAT THE GUIDE WIRE INTERACTED WITH OTHER DEVICES PRIOR TO USE AND CAUSED THE POLYMER DAMAGE AS REPORTED; HOWEVER, THIS COULD NOT BE CONFIRMED. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE PEELED POLYMER COATING AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE POLYMER COATING IS INSPECTED MULTIPLE TIMES DURING THE MANUFACTURING PROCESS. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEVICE UNPACKING AND BEFORE USE IN THE PATIENT, THE PHYSICIAN TOUCHED THE DISTAL PART OF THE GUIDE WIRE AND IT WAS NOTED THAT SOME DARK RESIDUE WAS PRESENT ON THE GLOVES. IT WAS SUSPECTED TO BE THE COATING FROM THE DISTAL SECTION OF THE GUIDE WIRE. THE DEVICE WAS NOT USED IN THE ANATOMY, BUT WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. A DIFFERENT GUIDE WIRE FROM THE SAME BOX/LOT WAS USED AND NO RESIDUE WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PILOT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0120102

    Patients

    Seq Age Sex Outcome Treatment
    1