BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 1903758 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02469
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 12, 2010
    Manufacturer
    AV-MURRIETA
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND BLOOD AND CONTRAST ON THE CORE, WHICH IS NOT CONSISTENT WITH THE REPORTED INFORMATION THAT THERE WAS NO PATIENT INVOLVEMENT. ALTHOUGH NOT REPORTED, THE TIP AND POLYMER WERE SEPARATED 29.6 CM DISTAL TO THE PROXIMAL END OF THE POLYMER. THE SEPARATED PORTION, INCLUDING THE TIP BALL, WAS NOT RETURNED. THERE WAS A BEND IN THE CORE 1.6 CM PROXIMAL TO THE SEPARATION. THE POLYMER WAS WRINKLED PROXIMAL TO THE SEPARATION FOR A LENGTH OF 2 MM. THE POLYMER MATERIAL AT THE SEPARATION WAS TORN AND WRINKLED. THE TEFLON WAS SCRAPED 4.3 CM DISTAL TO THE PROXIMAL END OF THE TEFLON FOR A LENGTH OF 5 MM. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS SUGGESTED THAT THE SEPARATION APPEARS TO BE ATTRIBUTED TO A TENSILE OVERLOAD. AN OVERLOAD OF THIS TYPE SUGGESTS THE CORE WAS EXPOSED TO PULLING FORCES BEYOND THE MATERIAL LIMITATIONS. THIS TYPE OF FORCE WOULD REQUIRE THE TIP TO BE TRAPPED WHILE EXTREME PULLING FORCE WAS APPLIED TO THE PROXIMAL END OF THE WIRE. THE ADDITIONAL DAMAGE AND SCRAPPED TEFLON NOTED ARE ALSO LIKELY THE RESULT OF SUCH MANIPULATION/FORCE APPLIED TO THE WIRES AND/OR INTERACTION WITH ASSOCIATED DEVICES. THE EXTENSIVE DAMAGE NOTED TO THE RETURNED GUIDE WIRE WAS NOT INITIALLY REPORTED AND IS LIKELY DUE TO USER MISHANDLING OF THE GUIDE WIRE. THERE IS NO INDICATION TO SUGGEST ANY TYPE OF PRODUCT RELATED DEFICIENCY. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. MANUFACTURING INSPECTS 100% OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE HI-TORQUE PILOT GUIDE WIRE ((B)(4)) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PILOT 150 GUIDE WIRES COULD NOT BE SHAPED; THEREFORE, WERE NOT USED IN THE PATIENT. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT WITH THE TWO GUIDE WIRES. THIS IS BEING REPORTED BASED ON THE EXAMINATION OF THE RETURNED GUIDE WIRE COMPLETED ON (B)(6) 2010, WHICH REVEALED THAT THE GUIDE WIRE TIP WAS SEPARATED AND WAS NOT RETURNED. THE GUIDE WIRE WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PILOT GUIDE WIRE GUIDE WIRE DQX AV-MURRIETA 0061603

    Patients

    Seq Age Sex Outcome Treatment
    1