BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 3170968 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03742
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE STENT DELIVERY SYSTEM WAS UNABLE TO BE CONFIRMED; HOWEVER THE DEVICE OPERATING DIFFERENTLY AND DAMAGE TO THE GUIDE WIRE WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN UNSPECIFIED CORONARY ARTERY, A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE CROSSED THE TARGET LESION. A 2.75X15 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE BMW ELITE, HOWEVER THE TIP OF THE SDS COULD NOT ADVANCE FURTHER BECAUSE THE BMW ELITE NON-MARKER TIN/SILVER SOLDER BECAME STACKED AT THE TIP OF THE SDS, AND THE SDS COULD NOT BE ADVANCED INTO THE TARGET LESION. THE BMW ELITE AND THE SDS WERE REMOVED AS A SYSTEM TOGETHER FROM THE PATIENT ANATOMY BECAUSE THE RX XIENCE PRIME SDS WAS DIFFICULT TO REMOVE FROM THE BMW. AFTER REMOVAL, THE BMW ELITE WAS REMOVED FROM THE XIENCE PRIME SDS OUTSIDE OF THE PATIENT WITHOUT DIFFICULTY. A NON-ABBOTT GUIDE WIRE CROSSED THE TARGET LESION AND THE SAME RX XIENCE PRIME SDS WAS RE-ADVANCED OVER THE NEW NON-ABBOTT GUIDE WIRE, AND THE STENT WAS DEPLOYED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED OCCURRENCE OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271336 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2110802

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 2.75X15 RX XIENCE PRIME