BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿

    MDR report key: 2840746 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07044
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPN - SEARCH CORRECTED FROM UNK122 - EPIC (PERIPHERAL INTERV) - 35000 TO H74939054051020 - EPIC OUS VAS 5X101X120 - 39054-05102. UPN CORRECTED FROM UNK122 TO H74939054051020. DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED DRIED BLOOD IN THE WIRE LUMEN. THE STENT WAS DEPLOYED 8 MM OUT THE END OF THE DISTAL SHEATH. THE SHAFT WAS KINKED 12 CM FROM THE TIP. THE OUTER DIAMETER OF THE WIRE WAS .034" WHICH IS CONSISTENT WITH A .035" GUIDEWIRE. THE INNER DIAMETER OF THE WIRE LUMEN IS WITHIN SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED BY LOADING THE ZIPWIRE INTO THE TIP AND ADVANCING THROUGH THE WIRE LUMEN ENCOUNTERING RESISTANCE AT THE SHAFT KINK. THE SDS WAS NOT LOCKED-UP ON THE GUIDEWIRE; HOWEVER, IT APPEARS THAT DIFFICULTY TRACKING THE GUIDEWIRE WAS ATTRIBUTABLE TO SHAFT DAMAGE. THE STENT WAS DEPLOYED PREMATURELY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-07043. IT WAS REPORTED THAT DURING AN AXILLARY ARTERY STENTING TREATMENT PROCEDURE A GUIDE WIRE BECAME STUCK. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. A .035 ZIPWIRE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION IN THE SUBCLAVIAN ARTERY IN THE LEFT ARM. DURING AN ATTEMPT TO ADVANCE AN EPIC SELF-EXPANDING NITINOL STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION, THE SDS BECAME STUCK AT THE MID PORTION OF THE ZIPWIRE GUIDE WIRE. FLUSHING WAS PERFORMED AND THE EPIC SELF-EXPANDING NITINOL SDS WAS PULLED BACK SLOWLY AND GENTLY BUT WAS UNABLE TO REMOVE. AS A RESULT, THE EPIC SELF-EXPANDING NITINOL STENT "FLOWERED" AND WAS IMPOSSIBLE TO DEPLOY NORMALLY. THE EPIC STENT REMAINED PARTIALLY DEPLOYED AND WAS REMOVED TOGETHER AS ONE UNIT WITH THE ZIPWIRE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZIPWIRE GUIDE WIRE AND EPIC SELF-EXPANDING NITINOL SDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-07043. IT WAS REPORTED THAT DURING AN AXILLARY ARTERY STENTING TREATMENT PROCEDURE, A GUIDE WIRE BECAME STUCK. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. A .035 ZIPWIRE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION IN THE SUBCLAVIAN ARTERY IN THE LEFT ARM. DURING AN ATTEMPT TO ADVANCE AN EPIC SELF-EXPANDING NITINOL STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION, THE SDS BECAME STUCK AT THE MID PORTION OF THE ZIPWIRE GUIDE WIRE. FLUSHING WAS PERFORMED AND THE EPIC SELF-EXPANDING NITINOL SDS WAS PULLED BACK SLOWLY AND GENTLY BUT WAS UNABLE TO REMOVE. AS A RESULT, THE EPIC SELF-EXPANDING NITINOL STENT "FLOWERED" AND WAS IMPOSSIBLE TO DEPLOY NORMALLY. THE EPIC STENT REMAINED PARTIALLY DEPLOYED AND WAS REMOVED TOGETHER AS ONE UNIT WITH THE ZIPWIRE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZIPWIRE GUIDE WIRE AND EPIC SELF-EXPANDING NITINOL SDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054051020 14561021

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GUIDE WIRE, .035 ZIPWIRE