BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2897194 · Received January 4, 2013

    Report

    Report Number
    2024168-2013-00074
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). (SUBSEQUENT TO THE INITIAL MEDWATCH ADDITIONAL INFORMATION RECEIVED IDENTIFYING THE DEVICE CATALOG AND LOT NUMBERS). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED GUIDEWIRE SEPARATION WAS CONFIRMED. BASED ON A VISUAL INSPECTION 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 014 NON-ABBOTT, PERIPHERAL DILATATION BALLOON, WAS USED IN THE TIBIO-PERONEAL TRUNK AND THE CASE WAS COMPLETED AT THIS POINT. THE BALLOON WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE BALANCE MIDDLE WEIGHT (BMW) GUIDEWIRE WAS ALSO EASILY REMOVED FROM THE ANATOMY, WITH NO RESISTANCE NOTED, BUT THE RADIOPAQUE TIP OF THE WIRE, THE COILED SEGMENT, CAME OFF IN THE SHEATH DURING REMOVAL. THEY CHECKED THE PATIENT AND THERE WAS NO WIRE LEFT IN THE PATIENT. THE SEPARATED SEGMENT HAD REMAINED IN THE SHEATH. THE ANTI-COAGULANT WAS REVERSED WITH PROTAMINE. THE SHEATH WAS PULLED AND MANUAL PRESSURE WAS APPLIED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5092 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1100371

    Patients

    Seq Age Sex Outcome Treatment
    1