ZIMMON BILIARY STENT
Report
- Report Number
- 3001845648-2019-00029
- Event Type
- Malfunction
- Date Received
- January 24, 2019
- Date of Event
- December 27, 2018
- Report Date
- February 19, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 00827002217072
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 DEVICE EVALUATION THE ZSO-7-10 DEVICE OF LOT NUMBER C1538643 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6)2019. A KINK WAS OBSERVED AT THE 02ND AND 05TH PORTHOLES AT THE TAPERED END OF THE STENT. THE 02ND PORTHOLE WAS OBSERVED TO HAVE BEEN PERFORATED BY THE WIRE GUIDE. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZSO-7-10 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. AS PER STEP 3 IN FINAL QUALITY CONTROL THE MANUFACTURING TEAM MEMBER (MTM) IS INSTRUCTED TO "INSPECT FOR DEBRIS IN OR ON PRODUCT, KINKS. CLEAN PRODUCT (EXTERNAL ONLY) FOR DEBRIS IF NECESSARY WITH LINT FREE WIPE". ADDITIONALLY, THE MANUFACTURING TEAM MEMBER (MTM) IS INSTRUCTED TO ¿VERIFY SIZE OF WIRE GUIDE BEFORE EACH USE. INSERT WIRE GUIDE INTO BOTH ENDS OF STENT.¿ A REVIEW OF THE MANUFACTURING RECORDS FOR ZSO-7-10 OF LOT NUMBER C1538643 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1538643. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045-6) STATES THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ ¿CARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS IN ORDER TO AVOID KINKING OR BREAKING THE STENT.¿ 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 THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE 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 THE SMALLER DIAMETER 0.025¿ WIRE GUIDE OCCUPIES LESS SPACE IN THE LUMEN OF THE PIGTAIL STENT IT IS LIKELY THAT THE EXTENT OF THE CURVATURE OF THE PIGTAIL WILL BE GREATER WHEN A 0.025. AS PER ADDITIONAL INFORMATION RECEIVED THE USER USED A 0.025" WIRE GUIDE. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. A KINK WAS OBSERVED AT THE 02ND AND 05TH PORTHOLES AT THE TAPERED END OF THE STENT. THE 02ND PORTHOLE WAS OBSERVED TO HAVE BEEN PERFORATED BY THE WIRE GUIDE. 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.
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED BENT' AND 'DIFFICULT ADVANCEMENT'. BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS "KINK". THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-10.
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED BENT' AND 'DIFFICULT ADVANCEMENT'. BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-10.
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED BENT' AND 'DIFFICULT ADVANCEMENT'. BEFORE USING THIS PRODUCT FOR PROCEDURE, THE SIDE HOLE OF THIS PRODUCT PIGTAIL WAS KINK. THE WIRE GUIDE COULD NOT GET INTO THE ZSO-7-10.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67299 | ZIMMON BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G21707 | C1538643 | 00827002217072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |