BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 772533 · Received August 11, 2006

    Report

    Report Number
    2954755-2006-00008
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    July 12, 2006
    Report Date
    August 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER IS REPORTEDLY EXPERIENCED WITH FILTERWIRE PROCEDURES WITHOUT ANY PRIOR COMPLAINTS REPORTED. DIFFICULTY IN UNSHEATHING OF THE PROTECTION WIRE FROM THE DELIVERY SHEATH WAS REPORTED. RETURNED PRODUCT ANALYSIS ON THE EZ DELIVERY SHEATH SHOWED SEPARATION AT THE DUAL LUMEN PEBAX TUBING TO THE SHEATH CORE WIRE JOINT APPROX. 110 CM PROXIMAL FROM THE DISTAL TIP. THE AREA OF FAILURE SHOWED ELONGATION OF TUBING MATERIAL SUGGESTING TENSION WAS APPLIED TO THE JOINT. THE PRODUCT WAS RETURNED WITH THE PROTECTION WIRE UNSHEATHED FROM THE DELIVERY SHEATH TUBING SECTION BY APPROX. 10 CM. THE DELIVERY SHEATH SECTION WAS READILY MOVABLE OVER THE FILTERWIRE. NO EVIDENCE WAS OBSERVED OF THE PROXIMAL DELIVERY SHEATH EVER BEING PEELED FROM THE GUIDEWIRE (IF THE PROXIMAL END OF THE SHEATH SLIT WAS EVER ENGAGED). THE MEAN IN-VITRO TENSILE TESTING ON THAT JOINT IN VALIDATION TESTING WAS 8.96 1BF. (4.77 1BF. - 11.87 1BF.). A POSSIBLE EXPLANATIONN OF THE EVENT WAS THAT THE PEBAX TUBING SECTION OF THE EZ DELIVERY SHEATH WAS ENTIRELY INSIDE THE GUIDE AND THE GUIDE'S HEMOSTASIS VALVE WAS NOT OPENED ENOUGH TO ALLOW THE TUBING TO PASS THROUGH WHEN WITHDRAWN. IF THE PHYSICIAN DIDN'T REALIZE THE HEMOSTASIS VALVE WAS NOT SUFFICIENTLY OPEN, HE MAY HAVE MISTOOK THAT RESISTANCE FOR DIFFICULTY IN UNSHEATHING THE FILTERWIRE PROTECTION WIRE. AFTER FAILURE AT THAT JOINT, THE REMAINING DISTAL SECTION OF THE DELIVERY SHEATH WAS STILL OVER THE FILTERWIRE PROTECTION WIRE. THE PROTECTION WIRE AND REMAINING PART OF THE DELIVERY SHEATH WOULD BE RETRACTED TOGETHER AS A UNIT TO REMOVE IT FROM THE PATIENT. THIS WAS DONE ACCORDING TO THE REPORTED EVENT. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    WORKING IN THE BYPASS GRAFT LESION, THE EZ DELIVERY SHEATH PULLED APART AS IT WAS DEPLOYING THE FILTERWIRE. SEPARATION OF THE DELIVERY SHEATH OCCURRED INSIDE THE GUIDE CATHETER. ALL COMPONENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT THE FILTERWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION GUIDEWIRE NFA BOSTON SCIENTIFIC CORPORATION 20100-190 0513003

    Patients

    Seq Age Sex Outcome Treatment
    1 *