BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC?

    MDR report key: 3031505 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-02069
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 6, 2013
    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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE EPIC STENT DELIVERY SYSTEM WAS RECEIVED WITH A ZIPWIRE GUIDEWIRE. THE PULL GRIP WAS PARTIALLY PULLED BACK. THE DISTAL SHEATH PRESENTS INDICATIONS OF AXIAL COLUMN STRENGTH OVERLOAD RESULTING IN AN ACCORDION-LIKE APPEARANCE. THE STENT WAS PROTRUDING 14MM FROM THE DISTAL END OF THE DELIVERY SYSTEM. THE GUIDEWIRE WAS PROTRUDING 137.2CM FROM THE DISTAL TIP. GENTLY PULLING ON THE WIRE CONFIRMED THAT THE WIRE WAS STUCK IN THE LUMEN OF THE CATHETER. THE FINISHED DIAMETER OF THE GUIDEWIRE WAS FOUND TO BE WITHIN SPECIFICATION. THE INNER DIAMETER (ID) OF THE WIRE LUMEN WAS MEASURED AT THE PROXIMAL END OF THE CATHETER (LUER) AND WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, A CATHETER BECAME STUCK ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7X118X120MM EPIC STENT DELIVERY SYSTEM (SDS) WAS FLUSHED WITH 10CM OF SALINE. WHEN THE EPIC SDS WAS ADVANCED OVER A 035/260 ZIPWIRE GUIDE WIRE, THE DEVICE BECAME STUCK AT THE MID PORTION OF THE GUIDE WIRE AND WAS UNABLE TO BE WITHDRAWN. ATTEMPTS TO SEPARATE THE ZIPWIRE AND THE EPIC SDS VIA FLUSHING WITH HIGH AMOUNT OF SALINE MANY TIMES AND ATTEMPTS TO WITHDRAW THE WIRE "STRONGLY AND SLOWLY" WERE UNSUCCESSFUL. DURING THE ATTEMPTS TO WITHDRAW THE DEVICES THE STENT PARTIALLY DEPLOYED. THE ZIPWIRE AND THE EPIC WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, A CATHETER BECAME STUCK ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7X118X120MM EPIC STENT DELIVERY SYSTEM (SDS) WAS FLUSHED WITH 10CM OF SALINE. WHEN THE EPIC SDS WAS ADVANCED OVER A 035/260 ZIPWIRE GUIDE WIRE, THE DEVICE BECAME STUCK AT THE MID PORTION OF THE GUIDE WIRE AND WAS UNABLE TO BE WITHDRAWN. ATTEMPTS TO SEPARATE THE ZIPWIRE AND THE EPIC SDS VIA FLUSHING WITH HIGH AMOUNT OF SALINE MANY TIMES AND ATTEMPTS TO WITHDRAW THE WIRE "STRONGLY AND SLOWLY" WERE UNSUCCESSFUL. DUING THE ATTEMPTS TO WITHDRAW THE DEVICES THE STENT PARTIALLY DEPLOYED. THE ZIPWIRE AND THE EPIC WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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
    133756 EPIC? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054071220 15159829

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR