OASIS ONE ACTION STENT INTRODUCTION SYSTEM
Report
- Report Number
- 3001845648-2023-00445
- Event Type
- Malfunction
- Date Received
- June 7, 2023
- Date of Event
- April 18, 2023
- Report Date
- June 28, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THE 1 X OACL-10-7 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS OPEN TO CAPTURE THE INCORRECT SIZE WIRE GUIDE USED WITH REPLACEMENT DEVICE. THIS FILE IS RELATED TO PR 395273: THE STENT DEPLOYED PREMATURELY. USER /USE RELATED COMPLAINTS IS CONSIDERED FORESEEN MISUSE. ITS IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND /OR LABELLING REQUIREMENT. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND /LABEL. TRENDING WILL MONITOR IF ANY FURTHER INVESTIGATION IS REQUIRED. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. PRIOR TO DISTRIBUTION ALL OACL-10 -7 DEVICES ARE SUBJECTED TO VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE IN CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0096) STATES THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITIONS, DO NOT USE.¿. IT ALSO STATES "WIRE GUIDE DIAMETER AND INNER LUMEN OF WIRE-GUIDE DEVICE MUST BE COMPATIBLE" THERE IS EVIDENCE TO SUGGEST THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR CAN BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE REPLACEMENT DEVICE. 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 STATED A 0.025" WIRE GUIDE WAS USED. CONFIRMATION OF COMPLAINT: THE COMPLAINT CONFIRMED BASED ON CUSTOMER/OR REP TESTIMONY. SUMMARY: FAILURE IDENTIFIED: INCORRECT SIZE WIREGUIDE USED WITH REPLACEMENT DEVICE. CONFIRMED QUANTITY OF 1 DEVICE, USED. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF USER ERROR CAN BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE REPLACEMENT DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, 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.
PER REP - (B)(6) 2023 - THE STENT DEPLOYED PREMATURELY, WHICH RESULTED IN NEEDING TO USE A GRASPER TO RETRIEVE THE STENT FROM THE DUODENUM ((B)(4)- EMDR REF.-3001845648-2023-00383)). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE ((B)(4).PATIENT OUTCOME:6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO¿ IF YES, PLEASE DESCRIBE.6.3.1.2 WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? -NO6.3.1.3 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NO¿ IF YES, PLEASE DESCRIBE.6.3.1.4 DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NO¿ IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS.6.3.1.5 HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -NO6.3.1.6 HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NO¿ PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.PATIENT/EVENT INFO - NOTES:2.0 EXAMPLES OF RPN PREFIXES - CHBS, CHBSO, CLBS, CLSO(-SF), FS-OA, FS-PC, GC, GEPD, GPDS, GPSO(-SF), GPSOS(-SF), HGC, JPWS, OA, OACL, OATS, PC, SIS, SPSOF, SPSOS, TTSO, ZEBD, ZEPDF, ZEPDS, ZPSOF, ZPSOS, ZSO & ZSS* NOT APPLICABLE IF PROBLEM OCCURRED AT REMOVAL2.1 FOR ALL COMPLAINTS, ASK:2.1.1 DOES THE COMPLAINT RELATE TO: -PLACEMENT¿ DEVICE PLACEMENT¿ DEVICE REMOVAL¿ OBSERVATION PRIOR TO PATIENT CONTACT2.1.2 WHAT WAS THE TARGET LOCATION FOR THE STENT? -CBD2.1.3 PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. -NORMAL ENDOSCOPY UNIT CONDITIONS IN A CABINET2.1.4 *WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE?* -480 CM MET2 WIRE GUIDE .0252.1.5 WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? N/A, YES, NO -YES2.1.6 *WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? N/A, YES, NO* -YES2.1.7 WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? N/A, YES, NO -YES2.1.8 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? N/A, YES, NO -YES¿ IF YES, PLEASE INDICATE THE PROCEDURE PERFORMED. -SPHINCTEROTOMY2.1.9 DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? N/A, YES, NO -NO2.1.10 * IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED?* -ANOTHER DEVICE OF THE SAME TYPE2.1.11 WHAT INTERVENTION (IF ANY) WAS REQUIRED? -NONE2.1.12 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY -N/A2.1.13 WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? YES, NO -NO, NOT BEING RETURNED, DISPOSED OF BY CUSTOMER IF YES, PLEASE DETAIL ANY OTHER DEFECTS OBSERVED.2.2 FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK:2.2.1 HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? N/A, YES, NO -YES2.2.2 WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? -OLYMPUS 190 DUODENOSCOPE WITH 4.2 MM WORKING CHANNEL2.2.3 DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? N/A, YES, NO -UNKR2.2.4 PLEASE INDICATE THE LOCATION IN THE BODY WHERE THE STENT DEVICE WAS TO BE PLACED. I.E. BILIARY DUCT, PANCREATIC DUCT, OTHER. -CBD¿ IF OTHER, PLEASE SPECIFY.2.2.5 *WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? N/A, YES, NO * -UNKR2.2.6 *WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCTION SYSTEM IN PLACE TO THE TARGET LOCATION? N/A, YES, NO * -UNKR¿ HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE?2.2.7 HOW DID THE PHYSICIAN DETERMINE THE LENGTH OF THE STENT TO BE USED FOR THE PROCEDURE? -CLINICAL DISCRETION2.2.8 WHERE WAS THE STRICTURE LOCATED IN THE DUCT? -UNKR2.2.9 *WAS THE STRICTURE DILATED PRIOR TO PLACING THE DEVICE?* -DEVICE NOT PLACED¿ IF SO, PLEASE INDICATE WHAT DEVICE(S) WERE USED.2.2.10 *WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT THROUGH THE OBSTRUCTED AREA? N/A, YES, NO * -N/A2.2.11 AFTER PLACEMENT, WAS STENT POSITION VERIFIED? N/A, YES, NO -N/A¿ IF YES, PLEASE DESCRIBE HOW.2.2.12 PLEASE ESTIMATE THE AMOUNT OF TIME THE STENT WAS IN PLACE PRIOR TO THIS OCCURRENCE. -IT WAS NEVER IN PLACE2.2.13 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? N/A, YES, NO -NO¿ IF YES, PLEASE SPECIFY WHAT SECTION OF THE DEVICE BROKE OFF:2.2.14 PLEASE INDICATE WHETHER THE DEVICE BROKE IN THE ENDOSCOPE OR IN THE PATIENT. N/A, ENDOSCOPE, PATIENT -N/A2.2.15 WAS THE BROKEN DEVICE RETRIEVED? N/A, YES, NO -N/A¿ IF YES, PLEASE INDICATE WHAT TOOLS WERE USED DURING RETRIEVAL (E.G. BASKET, BALLOON, SNARE, FORCEPS ETC.):2.2.16 WERE ANY MODIFICATIONS MADE TO THE COMPLAINT DEVICE OR ACCESSORIES USED WITH THE DEVICE IN THIS PROCEDURE? (E.G. GUIDING CATHETER SHORTENED, STENT CUT ETC.) N/A, YES, NO -UNKR¿ IF YES, PLEASE INDICATE WHAT MODIFICATIONS WERE MADE:2.2.17 PLEASE INDICATE WHY THE MODIFICATIONS WERE NECESSARY.2.2.18 PLEASE INDICATE ANY OTHER ENDOSCOPIC ACCESSORIES (IF ANY) THAT CAME INTO CONTACT WITH THE STENT OR INTRODUCTION SYSTEM DURING THE PROCEDURE. -JUST WIRE GUIDE2.2.19 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A, YES, NO -NO2.2.20 WHAT INTERVENTION (IF ANY) WAS REQUIRED? -NO2.2.21 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY -N/A2.2.22 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO -NO IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1330888 | OASIS ONE ACTION STENT INTRODUCTION SYSTEM | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |