ZIMMON BILIARY STENT
Report
- Report Number
- 3001845648-2018-00569
- Event Type
- Malfunction
- Date Received
- December 11, 2018
- Date of Event
- November 12, 2018
- Report Date
- January 8, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 00827002217119
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER; K851962. 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) 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION.
510 (K) NUMBER; K851962. 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), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: 1 X ZSO-7-15 OF LOT # C1450582 WAS RETURNED TO CIRL FOR EVALUATION. THERE WERE NO DEFECTS HIGHLIGHTED AS A RESULT OF THE LAB EVALUATION THE LAB EVALUATION READS THE PHYSICIAN USED THE WRONG SIZE SENT FOR THE PROCEDURE. ENGINEERING HAVE GIVEN THEIR EVIDENCE BASED REASONS FOR COMING UP WITH THIS IN THE LAB. DOCUMENT AND IFU REVIEW: A REVIEW OF MANUFACTURING RECORDS FOR LOT # C1450582 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE EFFECTS THE ENTIRE LOT # C1450582 , A REVIEW OF THE COMPLAINTS HISTORY DETERMINED THAT THIS FAILURE HAS NOT OCCURRED PREVIOUSLY WITH LOT # C1450582. IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, (B)(4)-6, A CONTRAINDICATIONS IDENTIFIED INCLUDES AN ¿INABILITY TO PASS WIREGUIDE OR STENT THROUGH OBSTRUCTED AREA¿ AND THE USER IS ALSO 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¿. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. THE POSSIBLE ROOT CAUSE FOR THIS COMPLAINT IS THAT THE PHYSICIAN DIDN'T CHOOSE AN APPROPRIATE SIZE STENT FOR THE APPLICATION. THE INCORRECT WIRE-GUIDE WAS USED WHICH MAY HAVE GIVEN AN INDICATION AS TO WHETHER THE STRICTURE WAS TOO TIGHT FOR THE STENT AND HALTED THE PROCEDURE AT THAT POINT IN TIME. THE WIRE-GUIDE USED IN THE PROCEDURE WAS 0.025IN AND THE CORRECT WIRE-GUIDE THAT SHOULD HAVE BEEN USED IS 0.035IN. THERE IS NO TESTING TO SUPPORT THE USAGE OF THE 0.025IN WIRE-GUIDE. THE COMPLAINT IS CONFIRMED BASED ON THE LAB EVALUATION. SUMMARY: THIS COMPLAINT IS CONFIRMED BASED ON CUSTOMER 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 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)(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
THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE CHD.
THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE CHD. FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF "DIFFICULT ADVANCEMENT". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE CHD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 990875 | ZIMMON BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G21711 | C1450582 | 00827002217119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |