ZIMMON BILIARY STENT SET
Report
- Report Number
- 3001845648-2018-00325
- Event Type
- Malfunction
- Date Received
- July 19, 2018
- Report Date
- September 13, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER AN OLYMPUS' VISIGLIDE 2 WIRE GUIDE. HOWEVER THE WIRE GUIDE TIP PENETRATED THE STENT. HE MANAGED TO ADVANCE IT OVER THE WIRE GUIDE AND PLACED IT AT THE TARGET SITE. CUSTOMER'S COMMENT: I'M USED TO THIS PRODUCT. I WOULD LIKE TO KNOW THE CAUSE OF THE OCCURRENCE. SALES REP'S COMMENT: I WOULD LIKE TO KNOW IF THERE ARE SIMILAR EVENTS HAVE REPORTED TO CIRL AND THE CAUSE. 1X ZEBD-7-7 OF UNKNOWN LOT NUMBER IS INVOLVED IN THIS COMPLAINT. LAB EVALUATION: THE 1X ZEBD-7-7 OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO CIRL FOR AN EVALUATION AND THERE WERE NO PHOTOGRAPHS PROVIDED BY THE CUSTOMER THEREFORE A LIMITED DOCUMENTATION BASED INVESTIGATION WAS COMPLETED. INPUT FROM ENGINEERING WAS RECEIVED TO ANSWER A NUMBER OF QUESTIONS WHICH STATED; WOULD HIGH FORCE BE REQUIRED TO PENETRATE THE STENT WITH THE WIREGUIDE? YES COULD A DAMAGED WIREGUIDE PENETRATE THE STENT? CERTAINLY ¿ IF THE PLASTIC SHEATH COVERING THE WIREGUIDE HAS BEEN REMOVED IT WILL INCREASE THE CHANCES. IS THERE A FLOPPY END ON THE WIREGUIDE SUPPLIED WITH THE STENT? NO WIRE GUIDE IS SUPPLIED WITH THE STENT COULD THIS BE ATTRIBUTED TO USER ERROR ETC? YES ¿ CHANCES ARE THE PHYSICIAN DID NOT USE A 0.035¿ WIRE GUIDE AS INDICATED BY THE LABEL. IF A 0.025¿ WIREGUIDE IS USED THE IT WILL TRAVEL THROUGH THE STENT WALL MUCH EASIER AS IT HAS A SMALLER TIP. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. DOCUMENTATION REVIEW: A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE COMPLAINTS HISTORY DETERMINED THAT THERE HAVE BEEN NO COMPLAINTS RECEIVED WHICH STATED THAT THE WIREGUIDE HAS PERFORATED THE STENT IN THIS PRODUCT. PRD/FQC/PKG REVIEW: PRIOR TO DISTRIBUTION, ALL DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THERE IS 100% INSPECTION ON ALL STENTS FOR KINKS AND A CHECK THAT THE APPROPRIATE SIZE WIRE GUIDE MOVES SMOOTHLY AND FREELY WHEN INSERTED INTO BOTH ENDS OF THE STENT. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0045-6, THE USER IS INSTRUCTED TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0045-6, THE USER IS ADVISED OF THE FOLLOWING: ¿CARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS* IN ORDER TO AVOID KINKING OR BREAKING THE STENT". ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED TO CIRL FOR EVALUATION AND THE EXACT OPERATIONAL CONDITIONS OF USE ARE UNKNOWN. A PROBABLE ROOT CAUSE FOR THIS COMPLAINT MAY BE ATTRIBUTED TO A DAMAGED WIREGUIDE BEING USED, A WIREGUIDE SMALLER THAN THE RECOMMENDED 0.035 SIZE OR EXCESSIVE FORCE BEING APPLIED WHEN PASSING THE WIREGUIDE RESULTING IN THE WIREGUIDE PERFORATING THE STENT. IN RESPONSE TO THE CUSTOMER AND COOK REPRESENTATIVE¿S QUESTIONS, ON REVIEW OF THE COMPLAINT HISTORY THE WIREGUIDE HAS ONLY PERFORATED/ PENETRATED THE STENT ONCE BEFORE AND THAT OCCURRENCE IS RELATED TO THIS OCCURRENCE, FOR THE PREVIOUS OCCURRENCE THE STENT WAS FOUND TO BE KINKED AT PORTHOLE 5 ON THE DUCTAL END WHICH MAY HAVE ATTRIBUTED TO THE WIREGUIDE PERFORATION. A LIKELY CAUSE OF THE WIREGUIDE PERFORATING THE STENT COULD BE ATTRIBUTED TO EITHER A WIREGUIDE USED THAT IS SMALLER THAN THE 0.035 RECOMMENDED WIREGUIDE AS PER THE PRODUCT LABEL, AND/OR FORCE BEING APPLIED WHEN PASSING THE WIREGUIDE, THE INPUT THAT WAS GATHERED FROM ENGINEERING STATES THAT A SUBSTANTIAL AMOUNT OF FORCE WOULD BE REQUIRED TO PERFORATE THE STENT WHEN USING THE RECOMMENDED SIZE WIREGUIDE, LESSER FORCE WOULD BE REQUIRED WHEN USING A SMALLER SIZE WIREGUIDE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
REPORT IS BEING SUBMITTED UNDER THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT¿. THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER AN OLYMPUS' VISIGLIDE 2 WIRE GUIDE. HOWEVER THE WIRE GUIDE TIP PENETRATED THE STENT. HE MANAGED TO ADVANCE IT OVER THE WIRE GUIDE AND PLACED IT AT THE TARGET SITE.
REPORT IS BEING SUBMITTED UNDER THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT¿. THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER AN OLYMPUS' VISIGLIDE 2 WIRE GUIDE . HOWEVER THE WIRE GUIDE TIP PENETRATED THE STENT. HE MANAGED TO ADVANCE IT OVER THE WIRE GUIDE AND PLACED IT AT THE TARGET SITE.
REPORT IS BEING SUBMITTED UNDER THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT¿. THE USER STRAIGHTENED THE PIG TAIL OF THE STENT USING THE STRAIGHTENER AND ATTEMPTED TO ADVANCE IT OVER AN OLYMPUS' VISIGLIDE 2 WIRE GUIDE . HOWEVER THE WIRE GUIDE TIP PENETRATED THE STENT. HE MANAGED TO ADVANCE IT OVER THE WIRE GUIDE AND PLACED IT AT THE TARGET SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543913 | ZIMMON BILIARY STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |