BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2630242 · Received June 27, 2012

    Report

    Report Number
    2024168-2012-04024
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    May 28, 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). 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 AND THE SHAPING RIBBON WAS NOTED TO BE SEPARATED. BASED ON VISUAL INSPECTION, 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 190 CM BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ADVANCED TO ACCESS THE DISTAL RIGHT CORONARY ARTERY WITH A TOTAL OCCLUSION. AN OTW DILATATION CATHETER WAS ADVANCED AND THE 190 CM GUIDE WIRE WAS REMOVED. CONTRAST WAS INJECTED THROUGH THE BALLOON TO SEE DISTAL FLOW TO VERIFY IF THEY WERE IN THE TRUE LUMEN. THE 300 CM BMW UNIVERSAL II WAS ADVANCED, BUT WAS UNABLE TO CROSS TO THE TARGET LESION. THE GUIDE WIRE TIP WAS NOTED TO BE FRAYED. THE BMW UNIVERSAL II GUIDE WIRE WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY. A NON-ABBOTT NEUROLOGICAL GUIDE WIRE WAS ADVANCED AND A SMALL PERFORATION OCCURRED CAUSED BY THE USE OF THE NEUROLOGICAL GUIDE WIRE. THE PATIENT WAS OBSERVED AND NO INTERVENTION WAS PERFORMED AS TREATMENT OF THE PERFORATION. THE CASE WAS THEN CONCLUDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION HAS BEEN 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 72 YR