BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM

    MDR report key: 3223582 · Received July 12, 2013

    Report

    Report Number
    1220452-2013-00035
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 16, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXE
    PMA / PMN Number
    K023878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4):THE COMPLAINT SAMPLE WAS NOT RETURNED. AS A RESULT, A VISUAL EXAMINATION, PHYSICAL MEASUREMENTS, AND FUNCTIONAL TESTING ARE NOT POSSIBLE AT THIS TIME. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR WOULD NOT DEFLATE. COMPLETE EVALUATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT THE COMPLAINT SAMPLE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A QUERY BY LOT NUMBER CANNOT BE PERFORMED IN THE COMPLAINT SYSTEM AS THE LOT NUMBER WAS NOT PROVIDED IN THIS COMPLAINT REPORT. THE PHYSICIAN FOLLOWED THE IFU INSTRUCTIONS: ¿IF THE BALLOON DOES NOT DEFLATE AFTER THE (ASPIRATION) PROCEDURE, AND AFTER FOLLOWING ALL THE PREVENTATIVE PROCEDURES, CUT THE WIRE DISTAL TO THE GOLD MARKER. ALLOW THE BALLOON TO FULLY DEFLATE, AS VERIFIED UNDER FLUOROSCOPY. REMOVE GUARD WIRE CATHETER AND DISCARD.¿ THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DISCREPANT DEVICE IS NOT POSSIBLE, DEVICE DISCARDED AND NOT RETURNING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT DURING THE CASE THE PHYSICIAN PLACED AND SUCCESSFULLY INFLATED THE DISTAL PROTECTION BALLOON AND SUCCESSFULLY STENTED. ASPIRATION WAS COMPLETED. WHEN TRYING TO DEFLATE THE DISTAL PROTECTION BALLOON IT WOULD NOT DEFLATE AND THEN THE WIRE BROKE ABOVE THE GOLD MARKER. EVEN WITH THE DISTAL PROTECTION DEVICE BROKEN THE BALLOON DID NOT DEFLATE. THE DEVICE WAS CUT TO DEFLATE THE BALLOON, THE CASE WAS COMPLETE SUCCESSFULLY WITHOUT PATIENT INJURY. THE DEVICE WAS DISCARDED AND NEEDS TO BE REPLACED.

    Description of Event or Problem · 1

    DURING THE CASE DR LEON PLACED AND SUCCESSFULLY INFLATED THE GUARD-WIRE BALLOON AND SUCCESSFULLY STENTED. ASPIRATION WAS COMPLETED. WHEN TRYING TO DEFLATE THE GUARD-WIRE BALLOON IT WOULD NOT DEFLATE AND THEN THE WIRE BROKE ABOVE THE GOLD MARKER. EVEN WITH THE GW BROKEN THE BALLOON DID NOT DEFLATE. THE GUARD WIRE WAS CUT TO DEFLATE THE BALLOON, THE CASE WAS COMPLETE SUCCESSFULLY WITH OUT PATIENT INJURY. THE DEVICE WAS DISCARDED AND NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323523 GUARDWIRE TEMPORARY OCCLUSION SYSTEM CATHETER, EMBOLECTOMY DXE MEDTRONIC INC. GEZUNK

    Patients

    Seq Age Sex Outcome Treatment
    1