LIGUORY NASAL BILIARY DRAINAGE CATHETER
Report
- Report Number
- 3001845648-2021-00789
- Event Type
- Malfunction
- Date Received
- November 4, 2021
- Date of Event
- October 9, 2021
- Report Date
- April 5, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002214580
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K180868. DEVICE EVALUATION: THE ENBD-7-LIGUORY-C DEVICE OF LOT NUMBER C1784554 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 13 DECEMBER 2021. ON EVALUATION OF THE DEVICE KINKS WERE OBSERVED ON THE 02ND, 4TH AND 05TH PORTHOLES ON THE PIGTAIL CURL AND A 0.035¿ WIRE GUIDE COULD NOT PASS THE KINKS ON THE PIGTAIL CURL. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ENBD-7-LIGUORY-C 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ENBD-7-LIGUORY-C OF LOT NUMBER C1784554 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 C1784554. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0099-0) STATES THE FOLLOWING: ¿NOTE: CARE MUST BE EXERCISED WHEN STRAIGHTENING PIGTAIL CURL IN ORDER TO AVOID KINKING OR BREAKING CATHETER.¿ THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A. 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 KINKING AS THE DRAINAGE CATHETER WAS STRAIGHTENED USING THE PIGTAIL STRAIGHTENER. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
USER ADVANCED THE DEVICE THROUGH WIRE GUIDE TO BILE DUCT WHILE FOUND OUT THE WIRE GUIDE CANNOT BE PUT THROUGH DRAINAGE CATHETER. USER RETRACTED THE DRAINAGE CATHETER FROM PATIENT AND FOUND OUT THE PIGTAIL END KINK. USER CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
ADDITIONAL INFORMATION: LAB EVALUATION COMPLETE ON 13-DEC-2021: KINKS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1649457 | LIGUORY NASAL BILIARY DRAINAGE CATHETER | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | C1784554 | 10827002214580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Female |