GEENEN PANCREATIC STENT SET
Report
- Report Number
- 3001845648-2018-00488
- Event Type
- Malfunction
- Date Received
- October 17, 2018
- Date of Event
- September 19, 2018
- Report Date
- November 14, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 00827002215757
- PMA / PMN Number
- K900923
- 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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. 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. LAB EVALUATION: AS THE GEPD-7-12 PRODUCT OF LOT C1477902 WAS RETURNED A PHYSICAL EVALUATION AND DOCUMENTATION BASED INVESTIGATION WAS COMPLETED. THE GEPD-7-12 DEVICE OF LOT C1477902 WAS EVALUATED IN THE LABORATORY ON 18/OCT/2018. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE FAILURE WAS IDENTIFIED IN THE LABORATORY; DURING THE LAB EVALUATION THE FLAPS ON THE TAPERED END WERE FOUND TO BE REMOVED AND THE STENT WAS SLIGHTLY SPLIT/ FRAYED WHERE THE FLAPS WERE REMOVED. THE FLAPS WERE NOT RETURNED. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE GEPD-7-12 DEVICE OF LOT NUMBER C1477902 INVOLVED IN THIS COMPLAINT DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO EVIDENCE TO SUGGEST THIS ISSUE EFFECTS THE ENTIRE LOT C1477902, UPON REVIEW OF THE COMPLAINTS HISTORY, THIS FAILURE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT C1477902. PRIOR TO DISTRIBUTION, ALL GEPD-7-12 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. IT SHOULD BE NOTED THAT COOK SELL GEENEN* PANCREATIC STENTS WITHOUT DUCTAL FLAPS (GPSOS), THE FLAPS ON THE GEENEN* PANCREATIC STENTS WITH DUCTAL FLAP (GEPD) SHOULD NOT BE REMOVED OR CUT OFF AS THIS WEAKENS THE STENT, INSTEAD THE USER SHOULD OPT FOR GEENEN* PANCREATIC STENTS WITHOUT DUCTAL FLAPS (GPSOS). IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0055-3, 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¿. THERE IS 100% INSPECTION ON STENTS FOR DAMAGE AND ALL GEPD LOTS ARE CHECKED TO ENSURE ALL NOTABLE CHARACTERISTICS ARE PRESENT AND THAT EACH FLAP IS INTACT. ROOT CAUSE: 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 THE STENT BECOMING DAMAGED WITHIN THE PACKAGE DURING TRANSPORT OR STORAGE OR BECOMING DAMAGED DURING PROCEDURE PREPARATION. IT SHOULD BE NOTED THAT THERE WAS CONFUSION REGARDING THE COMPLAINT DESCRIPTION, THE CUSTOMER STATED THAT THERE WAS A FRAY OR SPLIT IN THE STENT BUT WHEN THE REP LOOKED AT THE STENT HE NOTED THAT THE FLAPS WERE CUT OFF AND THERE WAS A SPLIT IN THE STENT WHERE THE FLAPS WERE REMOVED, THE REP SUGGESTED UPDATING THE COMPLAINT DESCRIPTION TO DESCRIBE WHAT HE HAD NOTED RATHER THAN WHAT THE CUSTOMER DESCRIBED I.E THE FLAPS WERE REMOVED AND MISSING FROM THE STENT, TO CLARIFY THIS ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER BUT THE ANSWERS WERE NOT GIVEN BY THE CUSTOMER BUT INSTEAD GIVEN BY THE REP WHO STATED THAT " THE REP VISITED THE HOSPITAL, BUT DETAILS WERE NOT PROVIDED BY THE USER. PLEASE SEE REP¿S RESPONSES IN RED BELOW. "SO JUST TO CONFIRM, THE CUSTOMER STATES THAT THEY OPENED THE PACKAGE AND THERE WERE FLAPS MISSING OFF THE TAPERED END OF THE STENT? ¿ YES, THE CUSTOMER STATES THAT THERE WERE FLAPS MISSING OFF THE STENT, BUT IT COULD NOT BE CONFIRMED IF THEY FOUND THE ABNORMALITY BEFORE OR AFTER OPENING THE PACKAGE. ALL THE INFORMATION WE COULD OBTAIN WAS THAT THE CUSTOMER STATES THAT THERE WERE FLAPS MISSING OFF THE STENT DURING AN INSPECTION PRIOR TO USE. PLEASE ASK THE CUSTOMER THE FOLLOWING QUESTIONS AND ONCE WE RECEIVE THE REPLY THEN YOU CAN UPDATE THE DESCRIPTION IF THIS IS REQUIRED: WERE THE FLAPS REMOVED FROM THE TAPERED END OF THE DEVICE DURING PREPARATION? WHERE ARE THE FLAPS? - ASKU. WAS THERE ANY DAMAGE NOTICED ON THE DEVICE WHILE IT WAS STILL IN THE PACKAGE? - ASKU. WAS THERE ANY DAMAGE TO THE PACKAGING NOTED? - ASKU. WAS THE FLAP PROTECTOR OR ANY OTHER SLEEVE PLACED ONTO THE DEVICE? - ASKU. DID THE DEVICE COME INTO CONTACT WITH A SHARP OBJECT DURING UNPACKING FROM THE PACKAGING OR DURING PREPARATION? - ASKU". GIVEN NUMEROUS INSPECTIONS OF THE STENT PRIOR TO LEAVING COOK IRELAND IT IS UNLIKELY THAT THE STENT WAS SHIPPED WITH THE FLAPS REMOVED AND THE STENT SPLIT, GIVEN THAT BOTH FLAPS ON EITHER SIDES OF THE STENT WERE REMOVED IT IS UNLIKELY THAT THE STENT FLAPS WERE REMOVED BY DAMAGE SUSTAINED DURING TRANSPORT OR STORAGE OR ACCIDENTALLY DURING PREPARATION AS THE STENT WOULD HAVE TO HAVE CAME IN CONTACT WITH A SHARP OBJECT ON BOTH SIDES OF THE STENT AND THIS WOULD INVOLVE A VAST AMOUNT OF DAMAGE TO THE PACKAGING WHICH WOULD HAVE BEEN OBVIOUS TO THE CUSTOMER. IT IS MORE LIKELY THAT THE USER REMOVED THE FLAPS WITH A SHARP OBJECT SUCH AS A KNIFE OR SCISSORS DURING PREPARATION BUT THE STENT SPLIT OR "FRAYED" WHILE IT WAS BEING ALTERED. THIS SCENARIO MOST CLOSELY FITS THE CUSTOMERS COMPLAINT DESCRIPTION. IT SHOULD ALSO BE NOTED THAT A VARIATION OF THIS STENT IS SOLD WITHOUT FLAPS AND IT IS LIKELY THE CUSTOMER WAS ATTEMPTING TO ALTER THE STENT TO RESEMBLE THE OTHER VARIATION, HOWEVER AS THIS INFORMATION HAS NOT BEEN MADE AVAILABLE FROM THE CUSTOMER IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE THIS AS A ROOT CAUSE FOR THE CUSTOMER COMPLAINT. SUMMARY: COMPLAINT CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY WHERE THE STENT WAS FOUND TO BE SPLIT AND THE FLAPS REMOVED. THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT, THEREFORE THERE WAS NO IMPACT TO THE PATIENT. 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)(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.
THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE" THE DEVICE WAS TO BE PLACED IN THE BILE DUCT. THE USER FOUND THAT THE STENT WAS FRAYED DURING AN INSPECTION PRIOR TO USE, SO ANOTHER DEVICE WAS USED INSTEAD.
THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE." THE DEVICE WAS TO BE PLACED IN THE BILE DUCT. THE USER FOUND THAT THE STENT WAS FRAYED DURING AN INSPECTION PRIOR TO USE, SO ANOTHER DEVICE WAS USED INSTEAD.
THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE." THE DEVICE WAS TO BE PLACED IN THE BILE DUCT. THE USER FOUND THAT THE STENT WAS FRAYED DURING AN INSPECTION PRIOR TO USE, SO ANOTHER DEVICE WAS USED INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816491 | GEENEN PANCREATIC STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G21575 | C1477902 | 00827002215757 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |