BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 8159272 · Received December 13, 2018

    Report

    Report Number
    3001845648-2018-00582
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    October 19, 2018
    Report Date
    December 13, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; K121430. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS RETURNED AND EVALUATED IN THE LABORATORY ON (B)(6) 2018. FLEXOR KINKED PROXIMALLY. DOCUMENTS REVIEW INCLUDING IFU REVIEW: THE EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1525154 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS PER CUSTOMER TESTIMONY COMPLAINT DEVICE DID NOT MAKE CONTACT WITH PATIENT. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. STANDARD OPERATING PROCEDURES INCLUDE THE FOLLOWING CHECKS; "INSPECT FOR THE FOLLOWING: VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS"; "CLEAN THE MANDREL (35-151) WITH IPA AND ENSURE THERE ARE NO SHARP EDGES. IF REQUIRED, BUFF SHARP EDGES SMOOTH AND THEN CLEAN AGAIN. INSERT MANDREL (35-151) INTO THE FLEXORS"; "DEPLOY THE STENT APPROXIMATELY 50% AND RE-SHEATH IT TO ENSURE IT FUNCTIONS CORRECTLY. ENSURE THE STENT DOES NOT GET CAUGHT BETWEEN THE TIP AND FLEXOR DURING RE-SHEATHING." "ENSURE THAT THERE ARE NO SHARP EDGES OR DAMAGE TO THE FLEXOR TIP AREA. THE BUFFED SECTION OF THE FLEXOR SHOULD FEEL SMOOTH TO TOUCH." A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1525154 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1525154; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #C1525154. THE INSTRUCTIONS FOR USE IFU0062-5 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "IF THE PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE ( IFU0062-5). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO TRANSPORTATION, STORAGE FACILITIES OR HANDLING OF THE DEVICE DURING REMOVAL FROM PACKAGING. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS PER SOURCE DOC "FAULTY UPON OPENING DUE TO A KINK IN THE BLUE SHEATH". "AS PER COMPLAINT FORM": THE DEVICE WAS FOUND TO BE FAULTY ON OPENING DUE TO KINKED INTRODUCER.

    Description of Event or Problem · 0

    FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF "FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED". AS PER SOURCE DOC "FAULTY UPON OPENING DUE TO A KINK IN THE BLUE SHEATH". "AS PER COMPLAINT FORM": THE DEVICE WAS FOUND TO BE FAULTY ON OPENING DUE TO KINKED INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999567 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1525154 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1