BEUDAMED
    FDA Adverse Event Injury Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 3222721 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04332
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 SEPARATION WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND SEM 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 USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE TIGHTLY STENOSED POSTERIOR TIBIAL ARTERY LESION THE AV WINN 200T GUIDE WIRE WAS ADVANCED TO CROSS THE LESION BUT APPROXIMATELY 5 CM OF THE GUIDE WIRE TIP BECAME DETACHED IN THE VESSEL. THE GUIDE WIRE FRAGMENT WAS CAPTURED USING A SNARE DEVICE, HOWEVER, DURING REMOVAL A VESSEL DISSECTION OCCURRED IN EITHER THE EXTERNAL ILIAC OR THE COMMON FEMORAL ARTERY (CFA). THE PATIENT WAS TRANSFERRED TO SURGERY FOR TREATMENT. A BLOOD TRANSFUSION WAS REQUIRED DURING THE SURGERY. IT WAS NOTED THAT THE PATIENT HAD SURGERY AND WAS ALSO HAVING ANOTHER ENDOVASCULAR PROCEDURE ON (B)(6) 2013; THE PATIENT STATUS AFTER THE INITIAL SURGERY POST COMPLICATION WAS GOOD BUT THE PATIENT DEVELOPED AN ISCHEMIC LEG THROUGHOUT THE NIGHT AND REQUIRED ADDITIONAL ENDOVASCULAR INTERVENTION TO TREAT AN EXTERNAL ILIAC LESION AND POPLITEAL/PERONEAL LESIONS. THE PATIENT WAS REPORTED AS DOING WELL AND HAS BEEN RELEASED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322458 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 3032071

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R