BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT SET

    MDR report key: 18835497 · Received March 5, 2024

    Report

    Report Number
    3001845648-2024-00078
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    January 31, 2024
    Report Date
    July 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002214962
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL CLBS-8.5-9 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR CLBS-8.5-9 DEVICE OF LOT NUMBER C1924792 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE (IFU0045), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO 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". THE USER IS ALSO ADVISED AS PER THE PRECAUTIONS OF THE IFU, "REFER TO PACKAGE LABEL FOR MINIMUM CHANNEL SIZE REQUIRED FOR THIS DEVICE." AND "WIRE GUIDE DIAMETER AND INNER LUMEN OF WIRE-GUIDED DEVICE MUST BE COMPATIBLE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0045). IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER; ALTHOUGH THE INDICATION FOR STENT PLACEMENT WAS NOT DISCUSSED IN THE COMPLAINT REPORT, ENDOSCOPIC IMAGES ARE SUSPICIOUS FOR AN AMPULLARY MASS RESULTING IN BILIARY OBSTRUCTION. THE SINGLE KUB SUBMITTED FOR REVIEW DEMONSTRATES MULTIPLE ENDOSCOPICALLY PLACED BILIARY STENTS. ONE OF THE COTTON-LEUNG NON-PIGTAIL BILIARY STENTS IS MORE CRANIALLY DISPLACED COMPARED WITH THE ADJACENT STENTS AND CORRESPONDS WITH THE STENT THAT WAS INADVERTENTLY DEPLOYED WITHIN THE COMMON BILE DUCT. THE COMPLAINT REPORT DESCRIBES THE PHYSICIAN AS ADVANCING THE STENT WITH THE PUSHER, AND THAT IT "FELL INTO THE CBD". GIVEN THE LACK OF A CLEAR DESCRIPTION OF THE EVENTS THAT LED TO THIS COMPLICATION, I'M UNCERTAIN WHERE THE ACTUAL ERROR OCCURRED. IF THERE WAS NOT ENOUGH WIRE IN THE LIVER TO STABILIZE THE SYSTEM, AND THE STENT WAS ADVANCED OUT OF THE GUIDE CATHETER, OVER THE WIRE USING THE PUSHER, THIS COULD CAUSE THE WIRE TO BUCKLE IN A DILATED COMMON BILE DUCT RESULTING IN THE STENT DEPLOYMENT HIGHER THAN INTENDED. HOWEVER, AS IS DESCRIBED IN THE IFU THE GUIDE CATHETER SHOULD BE RETRACTED RATHER THAN PUSHING THE STENT FORWARD WITH THE PUSHER CATHETER ONCE THE STENT IS IN GOOD POSITION. IF THIS STEP WAS APPROPRIATELY FOLLOWED, I FIND IT DIFFICULT TO EXPLAIN HOW THIS COMPLICATION OCCURRED. OCCASIONALLY, THERE WILL BE BUILT UP RESISTANCE IN THE SYSTEM AS TRYING TO RETRACT THE GUIDING CATHETER WHILE HOLDING FORWARD PRESSURE ON THE PUSHER. IF THIS PROCESS IS FORCED, THIS CAN RESULT IN INADVERTENT JUMPING FORWARD OF THE PUSHER AND THE STENT CAN BE DEPLOYED IN AN UNINTENDED LOCATION. IF SIGNIFICANT RESISTANCE WAS ENCOUNTERED, IT SHOULD NOT BE FORCED, ALTHOUGH THERE IS NO DESCRIPTION OF THIS POTENTIAL EVENT TO SUPPORT THIS HYPOTHESIS. THERE IS NOTHING IN THE COMPLETE REPORT OR ON THE IMAGES SUBMITTED FOR REVIEW TO SUGGEST THAT THIS WAS A DEVICE MALFUNCTION AND IS MOST LIKELY RELATED TO A PHYSICIAN DEPLOYMENT ERROR. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION PROVIDED A 0.025" WIREGUIDE WAS USED. AN IMAGING REVIEW OF THE MIGRATED STENT STATED THAT A LACK OF SUFFICIENT WIRE IN ORDER TO PROVIDE STABILITY TO THE STENT COULD HAVE LED TO THE WIRE BUCKLING IN A DILATED COMMON BILE DUCT RESULTING IN THE STENT DEPLOYING HIGHER THAN INTENDED. CLINICAL INPUT RECEIVED CONFIRMED THAT THE USE OF A 0.025" WIREGUIDE, DUE TO ITS SMALLER DIAMETER AND CONSEQUENTLY PROVIDING LESS SUPPORT IN THE LUMEN OF THE STENT, COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT ACCIDENTLY DEPLOYING WHERE IT DID. THE USE OF THE INCORRECT SIZED WIREGUIDE BY THE PHYSICIAN CONTRIBUTED TO THE STENT HAVING LESS SUPPORT AND FALLING INTO THE COLON AS REPORTED. CAPA 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USER ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: CAPA PR387756 ADDRESSES ANY NECESSARY CORRECTIVE ACTIONS AS A RESULT OF THIS FAILURE MODE. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, THE DOCTOR ADVANCED THE STENT BY PUSHER AND IT WAS YET TO ARRIVE AT TARGET, THE STENT FELL INTO CBD BY COLON. CONFIRMED QUANTITY OF (B)(4) DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE DOCTOR CANNOT REMOVE THE MIGRATED STENT AT THE MOMENT AND THEREFORE IT IS SCHEDULED TO BE REMOVED IN THE NEXT ERCP PROCEDURE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION PROVIDED A 0.025" WIREGUIDE WAS USED. AN IMAGING REVIEW OF THE MIGRATED STENT STATED THAT A LACK OF SUFFICIENT WIRE IN ORDER TO PROVIDE STABILITY TO THE STENT COULD HAVE LED TO THE WIRE BUCKLING IN A DILATED COMMON BILE DUCT RESULTING IN THE STENT DEPLOYING HIGHER THAN INTENDED. CLINICAL INPUT RECEIVED CONFIRMED THAT THE USE OF A 0.025" WIREGUIDE, DUE TO ITS SMALLER DIAMETER AND CONSEQUENTLY PROVIDING LESS SUPPORT IN THE LUMEN OF THE STENT, COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT ACCIDENTLY DEPLOYING WHERE IT DID. THE USE OF THE INCORRECT SIZED WIREGUIDE BY THE PHYSICIAN CONTRIBUTED TO THE STENT HAVING LESS SUPPORT AND FALLING INTO THE COLON AS REPORTED. CAPA 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USER ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED.

    Description of Event or Problem · 0

    THE DOCTOR ADVANCED THE STENT BY PUSHER AND IT WAS YET TO ARRIVE AT TARGET, THE STENT FELL INTO CBD BY COLON. FINALLY, HE USED EXTRACTION BASKET TO REMOVE THE STENT IN CBD.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-JUL-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165560 COTTON-LEUNG BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1924792 10827002214962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention