BEUDAMED
    FDA Adverse Event Injury Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 3100649 · Received May 8, 2013

    Report

    Report Number
    2024168-2013-02883
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 AND DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). THE WINN GUIDE WIRE WAS ADVANCED UP TO THE ANKLE REGION; HOWEVER, BECAME CAUGHT SUBINTIMAL. THE GUIDE WIRE WAS PULLED BACK, BUT 3CM OF THE DISTAL END OF THE GUIDE WIRE SEPARATED IN THE EXTRALUMINAR AREA OF THE VESSEL. A NON-ABBOTT GUIDE WIRE WAS THEN ADVANCED, BUT ALSO BECAME CAUGHT IN THE VESSEL AND SEPARATED. THE NON-ABBOTT GUIDE WIRE SEGMENT WAS NOT SUBINTIMAL; THEREFORE, IT WAS ASPIRATED THROUGH THE CATHETER. THE ATA WAS RE-CANALYZED DOWN TO THE ANKLE AND THE TIP OF THE WINN GUIDE WIRE REMAINS IN THE ANATOMY. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE WINN GUIDE WIRE CAUSED THE SUBINTIMAL FLAP. THE FINAL PATIENT OUTCOME WAS SATISFACTORY. NO FURTHER INTERVENTION WILL BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201973 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1072801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE CATH: 4F