BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUMA Z2 8F GUIDE CATHETER

    MDR report key: 2862767 · Received December 10, 2012

    Report

    Report Number
    1220452-2012-00068
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    January 29, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K982883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED GUIDE CATHETER REVEALED THAT THE DEVICE IS BLOODY INDICATING USE. THE HUB OF THE GUIDE CATHETER IS STILL ATTACHED TO THE SHAFT OF THE GUIDE CATHETER BY SOME REMAINING INTACT BRAID WIRES. THE SHAFT OF THE GUIDE CATHETER IS SEVERELY DAMAGED WHERE THE CATHETER SHAFT ENTERS THE HUB. TORSIONAL DAMAGE TO THE CATHETER SHAFT, WHERE IT ENTERS THE DISTAL END OF THE HUB, RESULTED IN THIS SECTION OF THE SHAFT NEARLY DETACHING FROM THE REST OF THE GUIDE CATHETER SHAFT. IT APPEARS THE STRAIN RELIEF WAS NOT FULLY INSERTED INTO THE GUIDE CATHETER HUB RESULTING IN THE STRAIN RELIEF ONLY BUTTING AGAINST THE SURFACE OF THE HUB. THIS POSSIBLY RESULTED IN THE CATHETER KINKING DUE TO TORQUING FORCES WHICH MAY HAVE BEEN ALLEVIATED IF THE STRAIN RELIEF WAS PROPERLY ASSEMBLED WITH THE HUB. CORRECTIVE ACTIONS HAVE BEEN TAKEN WITH THE RETRAINING THE OPERATORS WHO PERFORM THE GLUING PROCESS OF THE STRAIN RELIEF AND HUB. THE PROXIMAL END OF THE STRAIN RELIEF APPEARS SLIGHTLY BELLED OR FLARED. THE STRAIN RELIEF FROM THE GUIDE CATHETER WAS CUT AWAY FROM THE SHAFT IN ORDER TO TEST. USING IN-HOUSE 8F GUIDE CATHETER HUBS BOTH ONE AT A TIME, WERE INSERTED INTO THE INTACT DISTAL END OF THE STRAIN RELIEF WITHOUT ISSUE, THIS INDICATES THAT THE NON-FLARED OUTER DIAMETER OF THE STRAIN RELIEF WAS NOT A CONTRIBUTING FACTOR FOR AN ASSEMBLY ERROR. A REVIEW OF THE DEVICE HISTORY RECORD ID DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. THE COMPLAINT INVESTIGATION IS CONFIRMED. TORSIONAL DAMAGE TO THE CATHETER SHAFT, WHERE IT ENTERS THE DISTAL END OF THE HUB, RESULTED IN THIS SECTION OF THE SHAFT NEARLY DETACHING FROM THE REST OF THE GUIDE CATHETER SHAFT. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE THE HUB OF THE GUIDE CATHETER DETACHED FROM THE SHAFT. THE PHYSICIAN INSERTED THE GUIDE CATHETER AND INSERTED AN EXTRA SUPPORT GUIDE WIRE. THE PHYSICIAN HAD DIFFICULTY WIRING THE LESION. THE PHYSICIAN REMOVED THE GUIDE WIRE OUT. THE PHYSICIANS INSERTED A DIFFERENT GUIDE WIRE INTO THE PATIENT AND HAD DIFFICULTY WITH THE GUIDE WIRE. THE PHYSICIAN REMOVED THE SECOND GUIDE WIRE AND NOTICED IT WAS DAMAGED. THE PHYSICIAN THEN INSERTED ANOTHER GUIDE WIRE AND THEN THE PHYSICIAN REMOVED THE GUIDE WIRE AND NOTICED THAT THE HUB OF THE GUIDE CATHETER HAD SEPARATED FROM THE SHAFT OUTSIDE THE PATIENT. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED WITHOUT ISSUES. THERE WERE NO ADVERSE TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZUMA Z2 8F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTORNIC, INC 0006161833

    Patients

    Seq Age Sex Outcome Treatment
    1