ZIMMON BILIARY STENT SET
Report
- Report Number
- 3001845648-2024-00082
- Event Type
- Injury
- Date Received
- March 5, 2024
- Date of Event
- February 6, 2024
- Report Date
- June 19, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K851962. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: USER/USE RELATED COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. THE DEVICE EVALUATION FOR THE ZEBD-7-10 DEVICE OF UNKNOWN LOT COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS FILE WAS OPEN TO CAPTURE THE USER ERROR OF THE INCORRECT WIREGUIDE USED WITH THE REPLACEMENT STENT. (B)(4) / MDR#3001845648-2024-00080 WAS OPEN TO CAPTURE THE KINK ON THE PIGTAIL OF THE ORIGINAL ZEBD-7-10 STENT. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: IT SHOULD BE NOTED THAT IN THE JAPANESE PACKAGING INSERT ((B)(4)) STATES: " CHOOSE A WIRE GUIDE WITH OUTER DIAMETER 0.035 INCH (0.89MM) FOR USE WITH THIS PRODUCT¿. THE JAPANESE PACKAGING INSERT ((B)(4)) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PACKAGING INSERT. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. IT IS KNOWN FROM THE AVAILABLE INFORMATION 0.025" WIRE GUIDE WAS USED. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE.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 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USER ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INCORRECT SIZE WIRE GUIDE WAS USED WITH THE REPLACEMENT DEVICE. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL.
ZEBD-7-10 WAS TO BE PLACED IN COMMON BILE DUCT WITH PAPILLA APPROACH VIA ENDOSCOPY. AFTER PERFORMED EST (ENDOSCOPIC PAPILLOTOMY), ZEBD-7-10, WHICH WAS STRAIGHTENED WITH A STRAIGHTENER, WAS ATTEMPTED TO PASS OVER A WIRE GUIDE WHICH WAS PLACED IN COMMON BILE DUCT, BUT THE PIGTAIL PART GOT KINKED AND IT COULDN'T PASS. THE PHYSICIAN USED ANOTHER SAME DEVICE (UNKNOWN LOT) STORED IN HOSPITAL WITH SAME WIRE GUIDE AND COMPLETED THE PROCEDURE. THIS FILE CAPTURES THE ADDITIONAL DEVICE USED OF AN UNKNOWN LOT WITH THE SAME WIRE GUIDE PATIENT OUTCOME: NO HEALTH HAZARD. PATIENT/EVENT INFO - NOTES: FOR ALL COMPLAINTS: 1 FOR ALL COMPLAINTS, ASK: DOES THE COMPLAINT RELATE TO:DEVICE PLACEMENT/DEVICE REMOVAL/OBSERVATION PRIOR TO PATIENT CONTACT PLS. REFER DESCRIPTION OF EVENT. 2 WHAT WAS THE TARGET LOCATION FOR THE STENT? COMMON BILE DUCT. 3 PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. IT WAS STORED IN STACKS. 4 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE?* BOSTON SCIENTIFIC/ENDOSELECTOR 25 5 WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 6 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES 7 WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 8 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? YES. 9 IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. 10 DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO. 11 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? PLS. REFER DESCRIPTION OF EVENT. 12 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO 13 WHAT INTERVENTION (IF ANY) WAS REQUIRED? 14 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? 15 WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? 16 WAS A STRAIGHTENER USED TO STRAIGHTEN THE STENT? YES. 17 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)WAS THE PACKAGE DAMAGED? NO. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 2 WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS/TJF-260V 3 DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? YES. 6 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? 7 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCTION SYSTEM IN PLACE TO THE TARGET LOCATION? 8 HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? 9 HOW DID THE PHYSICIAN DETERMINE THE LENGTH OF THE STENT TO BE USED FOR THE PROCEDURE? 10 WHERE WAS THE STRICTURE LOCATED IN THE DUCT? 11 WAS THE STRICTURE DILATED PRIOR TO PLACING THE DEVICE? NO. 12 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT THROUGH THE OBSTRUCTED AREA? 13 AFTER PLACEMENT, WAS STENT POSITION VERIFIED? 14 IF YES, PLEASE DESCRIBE HOW. 15 PLEASE ESTIMATE/INDICATE THE AMOUNT OF TIME THE STENT WAS IN PLACE DWELLING PRIOR TO THIS OCCURRENCE. 16 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO. 17 IF YES, PLEASE SPECIFY WHAT SECTION OF THE DEVICE BROKE OFF: 18 PLEASE INDICATE WHETHER THE DEVICE BROKE IN THE ENDOSCOPE OR IN THE PATIENT? 19 WAS THE BROKEN DEVICE RETRIEVED? 20 IF YES, PLEASE INDICATE WHAT TOOLS WERE USED DURING RETRIEVAL. 21 WERE ANY MODIFICATIONS MADE TO THE COMPLAINT DEVICE OR ACCESSORIES USED WITH THE DEVICE IN THIS PROCEDURE? ¿ FOR EXAMPLE GUIDING CATHETER SHORTENED. NO. 22 IF YES, PLEASE INDICATE WHAT MODIFICATIONS WERE MADE: 23 PLEASE INDICATE WHY THE MODIFICATIONS WERE NECESSARY. 24 PLEASE INDICATE ANY OTHER ENDOSCOPIC ACCESSORIES (IF ANY) THAT CAME INTO CONTACT WITH THE STENT OR INTRODUCTION SYSTEM DURING THE PROCEDURE. 25 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 26 WHAT INTERVENTION (IF ANY) WAS REQUIRED? 27 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? 28 WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? 29 IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 19-JUN-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1584248 | ZIMMON BILIARY STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |