BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 4713038 · Received April 17, 2015

    Report

    Report Number
    1820334-2015-00228
    Event Type
    Death
    Date Received
    April 17, 2015
    Date of Event
    March 18, 2015
    Report Date
    August 16, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002441545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S DATE OF DEATH HAS BEEN REQUESTED. IT WAS NOT AVAILABLE AT THE TIME OF THE REPORT. CATALOG #KCFW-6.0-18/38-45-RB-ANL0-HC. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE AND THE TRENDS REPORT WERE CONDUCTED DURING THE INVESTIGATION NO DEVICE WAS RETURNED TO ASSIST IN THIS INVESTIGATION. IT WAS REPORTED THAT, "A SELF EXPANDING STENT [DELIVERY SYSTEM] WAS POSITIONED IN LEFT ILIAC ARTERY. THE STENT DELIVERY HOUSING WAS RETRACTED TO DEPLOY STENT. A COPPER WIRE FROM EITHER THE STENT DELIVERY SYSTEM OR INTRODUCER SHEATH APPEARED TO CATCH A STRUT OF THE DISTAL STENT. AS HOUSING WAS PULLED BACK IT PULLED THE STENT TOWARDS THE PROXIMAL END OF THE [SHEATH]. THE ENTIRE SYSTEM COULD NOT BE FURTHER MANIPULATED." THE DIFFICULTY EXPERIENCED DURING THE PROCEDURE RESULTED IN SIGNIFICANT HARM TO THE PATIENT DUE TO THE SURGICAL REMOVAL OF THE INTRODUCER, STENT AND DELIVERY SYSTEM. QUALITY ENGINEERING RISK ASSESSMENTS (QERA) WAS CREATED TO ASSESS RISK TO PATIENT. ALTHOUGH IT WAS REPORTED THE PATIENT DIED ONE WEEK FOLLOWING THE PROCEDURE, IT CANNOT BE CONFIRMED THAT THE DEATH OCCURRED AS A RESULT OF THE REPORTED EVENT. A 6.0 FRENCH INTRODUCER IS COMPATIBLE WITH THE STENT DELIVERY PER BOSTON SCIENTIFIC EPIC VASCULAR SELF-EXPANDING STENT SYSTEM DIRECTIONS FOR USE HTTP //WWW BOSTONSCIENTFIC.COM/CONTENT/DAM/MANUALS/US/CURRENT-REV-EN/90696699-OIA_EPIC-DFUUSS PDF QUALITY CONTROL IN-PROCESS AND INCOMING VENDOR INSPECTION OF THE SHEATH, REQUIRES INSURANCE THAT THERE IS NO COIL SEPARATION OR BREAKAGE. ALSO INSPECTIONS TO INSURE MATERIAL IS FREE FROM SURFACE DEFECTS, BUMPS, BULGES AND PROTRUDING COILS BETWEEN PROXIMAL END OF COIL AND DISTAL END OF COIL AND TO INSURE GOOD BOND MELT, IF APPLICABLE. NO DIFFICULTY IS REPORTED WHEN INTRODUCING THE STENT DELIVERY SYSTEM TO THE TARGET LOCATION. ONLY WHEN THE STENT IS BEING DEPLOYED IS DIFFICULTY ENCOUNTERED. AT THIS POINT, THE STENT IS TO BE WELL BEYOND THE TIP OF THE INTRODUCER AND NOT CONTACTING. PER THE MANUFACTURERS DIRECTIONS FOR USE IN THE STENT DEPLOYMENT PROCEDURE, "ADVANCE THE DELIVERY SYSTEM UNTIL THE STENT RADIOPAQUE MARKERS (1) AND (2) ARE CENTERED OVER THE TARGET LESION." WARNING: IF UNABLE TO INITIATE RELEASE OF THE STENT OR IF STRONG RESISTANCE IS MET WITH THE INTRODUCTION OF THE DELIVERY SYSTEM, REMOVE THE ENTIRE SYSTEM FROM THE PATIENT AND INTRODUCE A NEW SYSTEM." THEREFORE, IT IS FEASIBLE THAT THE DIFFICULTY IN REMOVING THE INTRODUCER WAS CAUSED BY UNINTENDED CONTACT OF THE STENT WITH THE INTRODUCER DURING DEPLOYMENT. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION ¿ EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, TRENDS, DIMENSIONAL VERIFICATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROLS, DOCUMENTATION, DRAWINGS, MANUFACTURING INSTRUCTIONS, AND VISUAL INSPECTION OF THE RETURNED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE 6FR FLEXOR WAS RETURNED FOR EVALUATION IN PIECES ALONG WITH THE NON-COOK DELIVERY SYSTEM, NON-COOK STENT, AND NON-COOK WIRE. UPON RECEIPT, IT WAS NOTICED THAT THE FLEXOR SHEATH HAD ALREADY BEEN REMOVED FROM THE ASSEMBLY. THE PROXIMAL POLYTETRAFLUOROETHYLENE (PTFE) LINER AND PROXIMAL COIL OF THE FLEXOR WERE FOUND TO BE PULLED DOWN THROUGH THE SHEATH. THE LINER APPEARED TO BE DOUBLED UP STARTING AT APPROXIMATELY 262MM FROM THE DISTAL END OF THE HUB. THE DOUBLE LINER WAS PRESENT IN THE MIDDLE COMPONENT, WHICH ALSO CONTAINED PART OF THE EPIC DELIVERY SYSTEM. THE DISTAL COMPONENT OF THE SHEATH WAS UNDAMAGED, BESIDES THE CUT, WITH THE LUMEN FULLY PATENT. THE PROXIMAL COIL WAS ALSO PULLED DOWN THROUGH THE DELIVERY SYSTEM, WITH OVERLAPPING COIL STARTING APPROXIMATELY 90MM FROM THE DISTAL END OF THE HUB. LINER AND COIL WERE SURROUNDING THE NESTING REGION OF THE EPIC DELIVERY SYSTEM, WHICH HAD THE SHEATH FULLY EXTENDED DISTALLY. FINALLY A PORTION OF THE COIL WAS WRAPPED AROUND THROUGH THE STRUTS OF THE STENT. IT IS UNCLEAR WHAT CAUSED THE PTFE DELAMINATION AND STRIPPING OF THE COIL TO OCCUR DURING THE PROCEDURE. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF SPECIFICATION. THE FLARE REMAINING IN THE HUB WAS SECURE, AND INCLUDED THE PTFE LINER. EIGHT (8) PRODUCTS, INCLUDING 4 BALLOONS WERE SUCCESSFULLY USED PRIOR TO PLACEMENT OF THE EPIC DELIVERY SYSTEM WITHIN THE SHEATH. THE EPIC DELIVERY SYSTEM WAS TRACKED OVER A 0.014" WIRE, WHICH DOES NOT FILL THE LUMEN TO THE EXTENT THAT A 0.035" WOULD, WHICH IS RECOMMENDED IN THE IFU. THIS UNSUPPORTED LUMEN HAS THE POTENTIAL TO ALLOW THE DISTAL TIP OF THE DELIVERY SYSTEM TO SCRAPE ALONG THE WALL OF THE SHEATH. IT IS UNCLEAR HOW THE COIL AND LINER WAS DRAGGED FROM THE PROXIMAL END OF THE SHEATH TO THE DISTAL END OF THE SHEATH WITHOUT HIGH RESISTANCE FELT. NO RESISTANCE WAS NOTED IN THE PHYSICIAN'S REPORT. THEREFORE, A ROOT CAUSE COULD NOT BE INTENDED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE PROVIDED INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING A ILIAC SFA STENT PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY ANOTHER MANUFACTURERS STENT, THE STENT GOT CAUGHT ON THE DELIVERY SYSTEM. WHEN THE PHYSICIAN WENT TO REMOVE THE DELIVERY SYSTEM BACK THROUGH THE SHEATH, THEY WERE UNABLE TO DO SO. IT WAS NOTED THAT THE DELIVERY SYSTEM COULD NOT BE REMOVED THIS WAY. THE PT WAS TAKEN INTO SURGERY FOR REMOVAL. THE SURGICAL TEAM SUCCESSFULLY REMOVED THE STENT, THE DELIVERY SYSTEM AND THE INTRODUCER SHEATH DURING THE SURGERY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT HAS SINCE PASSED AWAY. THE REPORTER COULD NOT CONFIRM IF THIS EVENT CONTRIBUTED TO THE PT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ILIAC / SUPERFICIAL ARTERY STENT PROCEDURE FOR WHICH THE PATIENT WAS ADMITTED ON (B)(6) 2015, A SELF-EXPANDING STENT WAS POSITIONED IN THE LEFT ILIAC ARTERY. THE STENT DELIVERY HOUSING WAS RETRACTED TO DEPLOY THE STENT. A COPPER WIRE FROM EITHER THE NON-COOK STENT DELIVERY SYSTEM OR THE COOK INTRODUCER FLEXOR ANSEL GUIDING SHEATH APPEARED TO CATCH A STRUT OF THE DISTAL STENT. AS THE HOUSING WAS PULLED BACK, IT PULLED THE STENT TOWARDS THE PROXIMAL END OF THE STENT. THE ENTIRE SYSTEM COULD NOT BE FURTHER MANIPULATED. THE PATIENT WAS ADMITTED TO SURGERY FOR REMOVAL OF THE STENT, DELIVERY SYSTEM, AND THE INTRODUCER SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT HAS SINCE PASSED AWAY. THE REPORTER COULD NOT CONFIRM IF THIS EVENT CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258071 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC NA 5517685 00827002441545

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death STENT SYSTEM. DIRECTIONS FOR USE:| HTTP://WWW.BOSTONSCIENTIFIC.COM