NASAL BILIARY DRAINAGE SET
Report
- Report Number
- 3001845648-2021-00849
- Event Type
- Malfunction
- Date Received
- December 9, 2021
- Date of Event
- November 11, 2021
- Report Date
- March 15, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002215839
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K180868. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE ENBD-5 DEVICE OF LOT NUMBER C1760881 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 JANUARY 2022. ON EVALUATION OF THE DEVICE THE FOLLOWING WERE OBSERVED VISUAL INSPECTION: KINKS OBSERVED ON THE 2ND AND 4TH PORTHOLES OF THE PIGTAIL CURL. FUNCTIONAL INSPECTION: 0.035 INCH WIRE GUIDE DOES NOT PASS THE KINKS. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ENBD-5 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-5 OF LOT NUMBER C1760881 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 C1760881. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0129-0) STATES THE FOLLOWING: ¿CAUTION: 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. 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 DEVICE WAS STRAIGHTENED WITH THE PIGTAIL STRAIGHTENER. IT IS POSSIBLE THAT AS THE USER STRAIGHTENED THE DEVICE THE PORTHOLES ON THE PIGTAIL CURL KINKED. IT IS POSSIBLE THAT THE 02ND PORTHOLE BECAME PERFORATED AS THE USER ATTEMPTED TO ADVANCE THE WIRE GUIDE THROUGH THE KINKED DRAINAGE CATHETER. 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.
PMA/510(K) # K180868. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL FOLLOW UP REPORT IS BEING SUBMITTED DUE TO LAB EVALUATION COMPLETE ON 13 JAN 2022: VISUAL INSPECTION: KINKS OBSERVED ON THE 2ND AND 4TH PORTHOLES OF THE PIGTAIL CURL.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
THOUGH A PHYSICIAN ATTEMPTED TO ADVANCE A WIRE GUIDE (BOSTON'S JAGWIRE 0.035INCH) THROUGH THE STENT, IT COULD NOT BE ADVANCED, THEN KINK WAS CONFIRMED IN THE PIGTAIL. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. PHYSICIAN'S COMMENT: IT CANNOT BE DETERMINED IF THE STENT WAS ALREADY KINKED PRIOR TO USE OR BECAME KINKED DURING PROCEDURE. SALES REP'S COMMENT: I WAS NOT PRESENT AT THE PROCEDURE, SO DO NOT KNOW THE DETAILS. AS THIS IS A PRODUCT THAT THE PHYSICIAN USES ON A REGULAR BASIS, I DON'T THINK THERE WAS ANY PROBLEM IN THE WAY OF USE. ADDITIONAL INFORMATION FOR ALL COMPLAINTS: HOW WAS THE DEVICE STORED? UNKNOWN. WAS THE DEVICE FLUSHED BEFORE USE? YES. WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, CONTRAST, ETC.)? WATER. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? ALREADY STATED IN PATIENT/EVENT INFO TAB. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? ALREADY STATED IN PATIENT/EVENT INFO TAB. WHAT WAS THE TARGET LOCATION IN THE BODY FOR USE OF THIS DEVICE? BILE DUCT WAS THE PATIENT¿S ANATOMY TORTUOUS? NO. WHAT WAS THE PATIENT¿S PRE-EXISTING CONDITION(S)? ASKU. WAS THE DEVICE STRAIGHTENED WITH THE PIGTAIL STRAIGHTENER (IF APPLICABLE)? UNKNOWN . WAS THE ISSUE OBSERVED DURING DEVICE PREP, DURING ADVANCEMENT OR ON REMOVAL OF THE DEVICE FROM THE PATIENT? ALREADY STATED IN PATIENT/EVENT INFO TAB. WERE ANY ADDITIONAL DEFECTS OR ISSUES, OTHER THAN THE COMPLAINT ISSUE, OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK, BEND, BREAK ETC.)? NO. IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT WAS OBSERVED (E.G. KINK, BEND, BREAK) IF ADDITIONAL DEFECTS WERE IDENTIFIED, PLEASE STATE WHERE THE DEFECT WAS OBSERVED ON THE DEVICE. WAS THE PACKAGING DAMAGED PRIOR TO DEVICE USE? UNKNOWN. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? (SAME PROCEDURE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1863958 | NASAL BILIARY DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | C1760881 | 10827002215839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |