GORE TIPS SET, GORE® TIPS SHEATH, AND GORE TIPS NEEDLE
Report
- Report Number
- 3004193842-2023-00001
- Event Type
- Malfunction
- Date Received
- January 24, 2023
- Date of Event
- October 10, 2022
- Report Date
- March 30, 2023
- Manufacturer
- CREGANNA MEDICAL
- Product Code
- DYB
- UDI-DI
- 45391526210022
- PMA / PMN Number
- K152913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ONLY THE NEEDLE GUIDE CATHETER WAS RETURNED FOR EXAMINATION WHEN THIS REPORT WAS COMPLETED. DURING THE VISUAL AND MICROSCOPIC EXAMINATION, FLASH/DELAMINATION WAS OBSERVED ON THE NEEDLE GUIDE TIP SECTION.THE ROOT CAUSE IS CURRENTLY UNDER FURTHER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED. NOTE: REPORTING TO THE US FDA WILL BE COMPLETED BY CREGANNA MEDICAL REGULATORY AFFAIRS ON BEHALF OF BOTH THE MANUFACTURER AND THE IMPORTER. PER THE GORE FDA MDR EXEMPTION E2016013 CREGANNA (REGISTRATION NO. 3004193842) WILL SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY CREGANNA MEDICAL AND IMPORTED INTO THE UNITED STATES OF AMERICA (USA) BY W. L. GORE & ASSOCIATES, INC. (REGISTRATION NO. 2017233 ).
THIS FOLLOW-UP MDR IS TO GIVE AN UPDATE ON THE INVESTIGATION FINDINGS BY CREGANNA MEDICAL IN RELATION TO THIS EVENT AS FOLLOWS: THE COMPLAINT IS REPORTABLE AND THIS WAS ESCALATED TO THE QUALITY MANAGEMENT TEAM AND A CAPA WAS INITIATED IN CREGANNA MEDICAL. A POST LAUNCH RISK ASSESSMENT AND HEALTH HAZARD EVALUATION WERE PREPARED, WITH THE INPUT OF OUR MEDICAL EXPERT, TO ASSESS ANY POTENTIAL RISK TO PATIENTS. THE OUTCOME OF THESE ASSESSMENTS WAS THAT THE PROBABILITY THAT THE HAZARD WILL RESULT IN ADVERSE HEALTH CONSEQUENCES IS LOW. THE INFORMATION WAS REVIEWED BY THE CREGANNA MEDICAL PRODUCT REVIEW COMMITTEE, TOGETHER WITH THE INVENTORY RE-INSPECTION DATA, AND IT WAS DETERMINED THAT A FIELD ACTION IS NOT REQUIRED. A NEW INSPECTION METHOD HAS BEEN DEVELOPED AND VALIDATED. GORE TIPS INVENTORY AT THE GALWAY SITE HAS BEEN RE-INSPECTED PER THIS VALIDATED METHOD. UNITS DEEMED ACCEPTABLE PER THE VALIDATED INSPECTION HAVE BEEN RELEASED. BASED ON REVIEW OF GALWAY SITE INVENTORY AND THE PLRA AND HHE ASSESSMENTS, IT WAS CONFIRMED THAT NO REMEDIAL ACTION ON DEVICES IN THE DISTRIBUTION CENTRE WAS REQUIRED. THESE WERE RELEASED FROM HOLD. THE DEVICE WAS RETURNED AND ANALYSED. THE OBSERVATIONS MADE DURING THE ANALYSIS FOUND THE FOLLOWING: 1. THE PRODUCT WAS RECEIVED PACKAGED IN A CARDBOARD BOX. 2. THE PRODUCT GORE NEEDLE GUIDE WAS PACKAGED IN A SEALED BAG AND IDENTIFIED WITH THE COMPLAINT REFERENCE NUMBER. 3. THE DILATOR, AND NEEDLE WERE NOT RETURNED WITH THE NEEDLE GUIDE AS PART OF THE GORE TIPS SET. 4. THE INTRODUCER SHEATH WAS NOT RETURNED FOR EXAMINATION AT THE TIME OF THIS REPORT BEING COMPLETED, THUS THE REPORTED FAILURE INTRODUCER TIP DAMAGE COULD NOT BE CONFIRMED. 5. THERE WERE NO KINKS OR DAMAGE ON THE HUB OBSERVED ON THE NEEDLE GUIDE. 6. THERE WAS EXCESSIVE MATERIAL/FLASH OBSERVED ON THE NEEDLE GUIDE TIP SECTION. THE INTRODUCER SHEATH WAS NOT RETURNED FOR EXAMINATION AT THE TIME OF THIS REPORT BEING COMPLETED, THUS THE REPORTED FAILURE GORE TIPS SHEATH - SHEATH TIP - DAMAGED COULD NOT BE CONFIRMED. ONLY THE NEEDLE GUIDE CATHETER WAS RETURNED FOR EXAMINATION. DURING THE VISUAL AND MICROSCOPIC EXAMINATION, EXCESSIVE MATERIAL WAS OBSERVED ON THE NEEDLE GUIDE TIP SECTION. THE AS ANALYSED CLASSIFICATION HAS BEEN ASSIGNED AS GORE TIPS NEEDLE - NEEDLE GUIDE - DAMAGED. BASED ON A REVIEW OF THE RISK DOCUMENTATION AND INFORMATION AVAILABLE, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE GORE TIPS SET DEVICE. THE QUALITY PROCEDURE FOR TRANSJUGULAR LIVER ACCESS SET - SUB ASSEMBLY IN PROCESS INSPECTIONS WHICH IS A PFMEA-REFERENCED METHOD OF CONTROL FOR DEVICE DEFECTS IS BEING UPDATED TO INCLUDE AN INSPECTION FOR THE FAILURE MODE RAISED MATERIAL FOR P/N 139632-01 (NEEDLE GUIDE ASSEMBLY) AND THE QUALITY PROCEDURE FOR VISUAL STANDARDS FOR TRANSJUGULAR LIVER ACCESS SET COMPONENTS TO CLARIFY THE MAGNIFICATION REQUIRED FOR INCOMING INSPECTION AND OUTLINE AN EXAMPLE OF RAISED MATERIAL. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE AFFECTED LOT WAS COMPLETED AND FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE REVIEW OF THE FINISHED GOODS DOCUMENTATION DID NOT HIGHLIGHT ANY ANOMALIES. AS OF 27 MARCH 2023, WHEN THE REVIEW WAS COMPLETED, THERE WAS NO OTHER COMPLAINT ASSOCIATED WITH THE AFFECTED LOT NUMBER, FOR THE AS REPORTED FAILURE GORE TIPS SHEATH - SHEATH TIP - DAMAGED. FROM THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE PRESENT TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. INFORMATION PRINTED ON THE INNER AND CARTON LABELS ARE ACCURATE. BASED ON THE CAPA INVESTIGATION, IT WAS DETERMINED THAT THE PRIMARY ROOT CAUSE OF THE ISSUE IS DEFECTIVE MATERIAL P/N 139749-03 (NEEDLE GUIDE) THAT IS FROM A SUPPLIER. TO ADDRESS THE DEFECTIVE MATERIAL FROM THE SUPPLIER, A SCAR HAS BEEN RAISED. THIS WILL ADDRESS THE PRIMARY ROOT CAUSE AND ENSURES THE SUPPLIER REVIEWS THEIR PROCESS AND IDENTIFIES THE CAUSE OF THE RAISED MATERIAL ON P/N 139749-03 (NEEDLE GUIDE). THE SECONDARY ROOT CAUSE IS INADEQUATE INSPECTION AT CREGANNA MEDICAL TO DETECT THIS DEFECT. THE RELEVANT QUALITY INSPECTION PROCEDURES ARE BEING UPDATED AS MENTIONED ABOVE. FOLLOWING A FULL REVIEW OF ALL AVAILABLE INFORMATION RECEIVED, THE PROBABLE CONCLUSION CODE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS 'SUPPLIER MANUFACTURE'. THE DEFINITION OF 'SUPPLIER MANUFACTURE' IS:'COMPLAINTS IN WHICH PRODUCT FAILS TO MEET SPECIFICATION DUE TO THE MANUFACTURING PROCESS AT A SUPPLIER SITE (APPLIES TO COMPONENTS AND FINISHED GOODS).'' CREGANNA MEDICAL WILL CONTINUE TO MONITOR THESE COMPLAINT TYPES. NOTE: REPORTING TO THE US FDA WILL BE COMPLETED BY CREGANNA MEDICAL REGULATORY AFFAIRS ON BEHALF OF BOTH THE MANUFACTURER AND THE IMPORTER. PER THE GORE FDA MDR EXEMPTION E2016013 CREGANNA (REGISTRATION NO. 3004193842) WILL SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY CREGANNA MEDICAL AND IMPORTED INTO THE UNITED STATES OF AMERICA (USA) BY W. L. GORE & ASSOCIATES, INC. (REGISTRATION NO. 2017233 ).
- THIS FOLLOW-UP MDR IS TO GIVE AN UPDATE ON THE INVESTIGATION FINDINGS BY CREGANNA MEDICAL IN RELATION TO THIS EVENT AS FOLLOWS: ALL PRODUCT WITHIN MANUFACTURER AND DISTRIBUTOR CONTROL WAS PLACED ON HOLD AND AN INVESTIGATION WAS INITIATED. A RISK ASSESSMENT AND HEALTH HAZARD EVALUATION HAS BEEN PREPARED AND WITH THE INFORMATION CURRENTLY AVAILABLE IT WAS DETERMINED THAT THE PROBABILITY THAT USE OF THE PRODUCT WILL CREATE A HAZARD IS LOW. THE ROOT CAUSE IS CURRENTLY UNDER FURTHER INVESTIGATION WITH THE SUPPLIER. A FOLLOW UP REPORT WILL BE SUBMITTED. NOTE: REPORTING TO THE US FDA WILL BE COMPLETED BY CREGANNA MEDICAL REGULATORY AFFAIRS ON BEHALF OF BOTH THE MANUFACTURER AND THE IMPORTER. PER THE GORE FDA MDR EXEMPTION E2016013 CREGANNA (REGISTRATION NO. 3004193842) WILL SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY CREGANNA MEDICAL AND IMPORTED INTO THE UNITED STATES OF AMERICA (USA) BY W. L. GORE & ASSOCIATES, INC. (REGISTRATION NO. 2017233 ).
EVENT DESCRIPTION: IT WAS REPORTED THE PHYSICIAN SELECTED A GORE TIPS SET FOR A PROCEDURE. THE TIP OF THE INTRODUCER SHEATH WAS DAMAGED AND WAS NOT USED. THE PROCEDURE WAS CONCLUDED WITH A SECOND SHEATH. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT.
EVENT DESCRIPTION: IT WAS REPORTED THE PHYSICIAN SELECTED A GORE TIPS SET FOR A PROCEDURE. THE TIP OF THE INTRODUCER SHEATH WAS DAMAGED AND WAS NOT USED. THE PROCEDURE WAS CONCLUDED WITH A SECOND SHEATH. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT.
EVENT DESCRIPTION: IT WAS REPORTED THE PHYSICIAN SELECTED A GORE TIPS SET FOR A PROCEDURE. THE TIP OF THE INTRODUCER SHEATH WAS DAMAGED AND WAS NOT USED. THE PROCEDURE WAS CONCLUDED WITH A SECOND SHEATH. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 998076 | GORE TIPS SET, GORE® TIPS SHEATH, AND GORE TIPS NEEDLE | GORE TIPS SET | DYB | CREGANNA MEDICAL | 1V00126676 | 45391526210022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |