BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 3172739 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03767
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STRETCHED COILS AND RESISTANCE WITH THE BALLOON CATHETER WERE ABLE TO BE CONFIRMED. THE PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE (IFU) 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 PROVIDED, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CROSSING A HEAVILY CALCIFIED LESION IN THE NARROW PROXIMAL CIRCUMFLEX CORONARY ARTERY WITH SLIGHT RESISTANCE FELT AND FORCE APPLIED USING A 014 BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE, A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE BMW WITH RESISTANCE FELT AND FORCE APPLIED. THE NON-ABBOTT BDC WAS RETRACTED OVER THE BMW WITH RESISTANCE FELT, BUT NO FORCE APPLIED; SUBSEQUENTLY, BOTH DEVICES WERE WITHDRAWN FROM THE ANATOMY AS A SINGLE UNIT. THE GUIDE WIRE TIP COIL WAS NOTED TO BE STRETCHED. THE TIP COIL DID NOT APPEAR TO BE UNRAVELED AND THE TOTAL LENGTH OF THE GUIDE WIRE DID NOT APPEAR TO BE LONGER THAN SPECIFIED. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED WITH THE SAME NON-ABBOTT BDC TO COMPLETE THE PROCEDURE WITH A SATISFACTORY FINAL OUTCOME. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273030 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 2090571

    Patients

    Seq Age Sex Outcome Treatment
    1