BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 18607365 · Received January 30, 2024

    Report

    Report Number
    3001845648-2024-00036
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    December 21, 2023
    Report Date
    July 26, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163468. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163468. DEVICE EVALUATION THE EVO-25-30-10-C DEVICE OF LOT NUMBER C2057250 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH ITS OPENED ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 14TH FEBRUARY 2024. ON EVALUATION OF THE DEVICE, THE FOLLOWING WAS OBSERVED: VISUAL INSPECTION: ¿ RED SAFETY TAB NOT RETURNED. ¿ DIRECTIONAL BUTTON IN 'DEPLOYMENT' POSITION. ¿ SAFETY/LOCK WIRE IN PLACE UPON RETURN. ¿ RED SHUTTLE AT 09TH DIMPLE (BEFORE POINT OF NO RETURN). ¿ KINK NOTED DIRECTLY BELOW THE HANDLE. ¿ OUTER CATHETER BREAK NOTED APPROXIMATELY 28CM FROM WHITE TIP. FUNCTIONAL INSPECTION: ¿ HANDLE ACTUATING FINE FOR DEPLOYMENT AND RECAPTURE. ¿ UNABLE TO DEPLOY STENT DUE TO OUTER CATHETER BREAK. KINK AT HANDLE AND FLEXOR BREAK WERE BOTH OBSERVED BY THE CUSTOMER PRIOR TO RETURNING THE DEVICE TO COOK MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0052) STATES THE FOLLOWING: ¿IF 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. PLEASE NOTIFY COOK FOR RETURN AUTHORIZATION¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW : AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS : 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 HANDLING OF THE DEVICE DURING THE PROCEDURE OR DURING DEVICE PREP. THE KINK AT THE HANDLE MAY HAVE OCCURRED IF THE HANDLE WAS NOT ADEQUATELY SUPPORTED DURING USE. THE KINK AT THE HANDLE WOULD HAVE INCREASED DEPLOYMENT FORCE, CAUSING THE OUTER CATHETER TO STRETCH AND SEPARATE, SUBSEQUENTLY LEADING TO THE ISSUES REPORTED. THE KINK AT THE HANDLE AND OUTER CATHETER BREAK WERE OBSERVED IN THE LAB EVALUATION. 03 ATTEMPTS WERE MADE TO GAIN MORE INFORMATION ABOUT THIS EVENT, IF MORE INFORMATION BECOMES AVAILABLE, THE FILE CAN BE RE-OPENED AND UPDATED. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. CONFIRMED QUANTITY OF 01 X USED DEVICE. SUMMARY OF INVESTIGATION: 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 SIMILAR EVENTS.

    Description of Event or Problem · 0

    USER DETECTED THE STENT CANNOT BE RELEASED. USER CANNOT CONFIRM IF THE ISSUE WAS CAUSED BY THE SHEATH OR STENT. USER HAS MANY YEARS EXPERIENCE USING THE DEVICE, AND IT MAY NOT RELATED TO USER'S TECHNIQUE. PATIENT OUTCOME: "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 26-JUL-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550870 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD C2057250 10827002480381

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male