BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3999652 · Received August 11, 2014

    Report

    Report Number
    0002090040-2014-00028
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. HOWEVER, THE ORIGINAL STRYKER SUSTAINABILITY SOLUTIONS OPENED PACKAGING WAS RETURNED. THE REPORTED COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION, THEREFORE, FUNCTIONAL, VISUAL, AND DIMENSIONAL TESTING/INSPECTION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) INDICATES THE COMPLAINT DEVICE PASSED ALL INSPECTION PRIOR TO RELEASE FROM STRYKER SUSTAINABILITY SOLUTIONS (STRYKER). SINCE THE REPORTED COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION THE REPORTED ISSUE COULD NOT BE SUBSTANTIATED. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE IS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: ¿ MISHANDLING SUBSEQUENT TO DISTRIBUTION FROM STRYKER. ¿ RECEIVED TO STRYKER IN NONWORKING CONDITION. THIS REPORT IS BEING FILED DUE TO THE STENT BEING DEPLOYED IN AN UNINTENDED LOCATION AND LEFT IN THE PATIENT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIALYSIS GRAFT EVALUATION WITH DE-CLOT AND VASCULAR INTERVENTION PROCEDURE, "THE PAC ATRIUM BALLOON STENT STARTED TO SLIP OFF THE BALLOON, THEREFORE THEY HAD TO DEPLOY THE STENT IN AN UNINTENDED LOCATION IN THE PATIENT." THE STENT THAT WAS DEPLOYED IN THE UNINTENDED LOCATION WAS LEFT IN THE PATIENT. THEY USED ANOTHER DEVICE TO PLACE ANOTHER STENT WHERE THEY HAD ORIGINALLY INTENDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS CONFIRMED THAT THERE HAVE BEEN NO COMPLICATIONS FOR THE PATIENT AS A RESULT OF THE ADDITIONAL STENT BEING LEFT IN THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475761 NA CATHETER, EMBOLECTOMY DXE STRYKER SUSTAINABILITY SOLUTIONS LAKELAND UNUSED 461636U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other