PUSHING CATHETER
Report
- Report Number
- 3001845648-2021-00170
- Event Type
- Malfunction
- Date Received
- March 5, 2021
- Date of Event
- February 3, 2021
- Report Date
- January 15, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
1 X PC-7 OF LOT NUMBER UNKNOWN INVOLVED IN THIS COMPLAINT WAS UNAVAILABLE FOR RETURN TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS IS FILE IS LINKED TO PR (B)(6) (3001845648-2021-00222) FOR USER ERROR FOR DEVICE PC-7 THAT WAS KINKED THROUGH THE USE OF AN INCORRECT WIRE GUIDE. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL PC-7 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0130-0) STATES THE FOLLOWING: ¿REFER TO THE LABEL REGARDING THE SELECTION OF THE APPROPRIATE WIRE GUIDE¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN 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¿ WIRE GUIDE IS USED. AS PER ADDITIONAL INFORMATION RECEIVED A 0.025" WIRE GUIDE WAS USED. SUMMARY: 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 POTENTIAL EMERGING TRENDS.
PMA/510(K) # K172044 AND K172057 1 X PC-7 OF LOT NUMBER UNKNOWN INVOLVED IN THIS COMPLAINT WAS UNAVAILABLE FOR RETURN TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS IS FILE IS LINKED TO PR (B)(4) / MDR REF#3001845648-2021-00222 FOR USER ERROR FOR DEVICE PC-7 THAT WAS KINKED THROUGH THE USE OF AN INCORRECT WIRE GUIDE. LAB EVALUATION: N/A IMAGE REVIEW: N/A DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL PC-7 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0130-0) STATES THE FOLLOWING: ¿REFER TO THE LABEL REGARDING THE SELECTION OF THE APPROPRIATE WIRE GUIDE¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN 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¿ WIRE GUIDE IS USED. AS PER ADDITIONAL INFORMATION RECEIVED A 0.025" WIRE GUIDE WAS USED. SUMMARY: 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 POTENTIAL EMERGING TRENDS.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. AN UPDATE ANNEX C CODE IS REQUIRED. C19 - NO DEVICE PROBLEM FOUND WILL BE UPDATED TO C23 - USAGE PROBLEM IDENTIFIED.
THE DOCTOR WANTED TO INSERT THE ZSO-7-9 IN THE CBD. THE NURSE PASSED THE ZSO THROUGH THE WIRE (VISI2 0.025" ANGLE TYPE), AND THEN TRIED TO PASS THE PC-7 THROUGH THE WIRE, BUT THE WIRE DID NOT PASS THROUGH THE PC-7. AFTER SEVERAL ATTEMPTS IT FELT CLOGGED AND WAS IMPOSSIBLE. SO THEY USED THE NEW PC-7, THEY PASSED THE PC-7 ON THE SAME WIRE IN USE (VISI2 0.025" ANGLE TYPE) AND PASSED WITHOUT PROBLEMS. ZSO WAS PLACED AND THE PROCEDURE WAS COMPLETED.DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NODID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NODID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NOWERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NODID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316773 | PUSHING CATHETER | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |