BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2630192 · Received June 27, 2012

    Report

    Report Number
    2024168-2012-04022
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    May 27, 2012
    Report Date
    June 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EIGHT UNUSED DEVICES WERE RETURNED IN ASSOCIATION WITH THE REPORTED DEVICE ISSUE WITH THE SAME PART AND LOT NUMBER (1009665 / 2012571). ANALYSIS SHOWED THE UNUSED RETURNED DEVICES WITH NO DAMAGE NOTED AND ALL FUNCTIONAL TESTING MET MANUFACTURING CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STRETCHED COILS WERE CONFIRMED. ADDITIONALLY, THE RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY INDICATES THAT THE FACILITY CANNOT CONFIRM WHEN THE DEVICE SEPARATION OCCURRED. THE PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL INSPECTION, FUNCTIONAL TESTING, DIMENSIONAL MEASUREMENTS, AND SCANNING ELECTRON MICROSCOPY IMAGING 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, MULTIPLE GUIDE WIRES WERE USED VIA A FEMORAL-FEMORAL BYPASS BUT WERE UNABLE TO CROSS TO THE ASCENDING AORTA. THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS THEN ADVANCED; HOWEVER, DUE TO THE PATIENT'S ANATOMY AND THE FEMORAL-FEMORAL BYPASS, RESISTANCE WAS MET. THE BMW UNIVERSAL II GUIDE WIRE WAS ABLE TO ADVANCE TO THE TARGET SITE. DURING THE PROCEDURE, THE GUIDE WIRE TIP WAS NOTED TO BE FRAYED. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT'S ANATOMY WITHOUT DIFFICULTY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2012571

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR