132CM CEREGLIDE 71 CATHETER
Report
- Report Number
- 3007628272-2024-00036
- Event Type
- Malfunction
- Date Received
- July 8, 2024
- Date of Event
- June 3, 2024
- Report Date
- September 9, 2024
- Manufacturer
- CERENOVUS, INC.
- Product Code
- QJP
- UDI-DI
- 10886704085393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). BASED ON THE ANALYSIS OF THE PICTURE RECEIVED, THE DISTAL TIP WAS NOTED WITH ROUGH EDGE. THE FINDINGS MEET US REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION E1. INITIAL REPORTER PHONE: (B)(6). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. PRE-SHIPMENT PICTURES ACCOMPANIED THE COMPLAINT FILE SHOWS THE DISTAL TIP OF THE CEREGLIDE WITH TWO COMPRESSED CONDITIONS. ALSO, TWO FLATTENED SECTIONS WERE FOUND IN THE DEVICE. A DAMAGE WAS OBSERVED ON THE EDGE OF THE OF THE DISTAL TIP. ONE KINKED CONDITION WAS NOTED ON THE BODY OF THE CATHETER. THE TOTAL LENGTH OF THE DEVICE WAS 133.50CM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REGARDING A CATHETER BEING FLATTENED, KINKED AND ELONGATED WAS CONFIRMED DURING THE PHOTO INSPECTION BASED ON THE COMPRESSED AND KINKED CONDITIONS SEEN IN THE DEVICE. BASED ON THE TOTAL LENGTH OF THE CATHETER IT WAS DETERMINED THAT HAS BEEN ELONGATED 1.50 CM. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO CAPA ACTIVITY IS REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). A CORRECTION HAS BEEN MADE TO SECTION H6 AND THE PRODUCT INVESTIGATION SUMMARY: PRE-SHIPMENT PICTURES ACCOMPANIED THE COMPLAINT FILE SHOWS THE DISTAL TIP OF THE CEREGLIDE WITH TWO COMPRESSED CONDITIONS. ALSO, TWO FLATTENED SECTIONS WERE FOUND IN THE DEVICE. A DAMAGE WAS OBSERVED ON THE EDGE OF THE OF THE DISTAL TIP. ONE KINKED CONDITION WAS NOTED ON THE BODY OF THE CATHETER. THE TOTAL LENGTH OF THE DEVICE WAS 133.50CM THE PRODUCT WAS RETURNED TO CERENOVUS BLUE LAGOON FOR EVALUATION. - VISUAL: THE CATHETER WAS RECEIVED WITH SLIGHT MATERIAL NECKING JUST PROXIMAL TO THE DISTAL MARKER BAND FOR APPROXIMATELY 2 MM. THE INNER PTFE LINER IS DELAMINATED FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A SECTION. THE DELAMINATION EXTENDS TO APPROXIMATELY 5.0 CM FROM THE TIP, THE PROXIMAL END. THERE WERE AREAS ON THE CATHETER THAT WERE FLATTENED OR PARTIALLY FLATTENED. THE FIRST PARTIALLY FLATTENED AREA STARTED AT 17 CM PROXIMAL TO THE DISTAL TIP AND EXTENDED TO 30 CM FROM THE TIP. THE CATHETER WAS COMPLETELY CRUSHED FLAT / KINKED AT 17.5 CM DISTAL TO THE PROXIMAL ID BAND AND PARTIALLY FLATTENED FROM 18 CM THROUGH 21.5 CM FROM THE PROXIMAL ID BAND. AN ATTEMPT WAS MADE TO RECREATE THE DELAMINATION PHENOMENON BY STRETCHING PRODUCT RETAINS FROM LOT 31028722, WHICH WAS A LOT FROM THE ORIGINAL CEREGLIDE PQ/PVE FOR MANUAL MAGIC TOUCH. THE CATHETERS WERE STRETCHED SO THAT THE ORIGINAL ~5CM LONG SECTIONS WERE STRETCHED TO ~13 CM. AFTERWARD DEVICES WERE PASSED THROUGH THE LUMEN. NO DELAMINATION WAS ABLE TO BE CREATED ON THESE NOMINALLY FUSED PRODUCTS. - CONCLUSION: THE CATHETER TIP EXPERIENCED TENSION / ELONGATION OF THE DISTAL REGION OF THE CATHETER WHICH CAUSED THE INNER PTFE LINER TO DELAMINATE FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A MATERIAL. THIS DELAMINATION WAS LESS SEVERE THAN TWO OTHER COMPLAINTS FROM THE NETHERLANDS. BECAUSE OF THE FLATTENED SECTIONS FOUND ON THE CATHETER IN MULTIPLE SPOTS IT IS SUSPECTED THAT THE RHV USED ON THE CATHETER OD WAS TIGHTENED EXCESSIVELY CAUSING STRETCHING OF THE CATHETER WHILE WITHDRAWING FROM THE PATIENT. THE DELAMINATION FAILURE WAS NOT ABLE TO BE REPRODUCED BY EXTREME ELONGATION ON PRODUCT RETAINS FROM PQ PVE LOT 31028722. AS PART OF CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. SINCE NO ISSUES WERE IDENTIFIED, NO CAPA ACTIVITY IS REQUIRED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATION: - EXERCISE CARE IN HANDLING THE INTERMEDIATE CATHETER TO REDUCE THE CHANCE OF ACCIDENTAL DAMAGE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT #(B)(4). COMPLAINT CONCLUSION: IT WAS REPORTED THAT WHILE PULLING A 132CM THE CEREGLIDE 71 (NIC71132C, 31219631), THE TIP OF THE CEREGLIDE 71 SEEMED NOT TO MOVE THOUGH IT WAS BEING PULLED AT HAND. WHEN ALL OF THE PRODUCTS WERE PULLED OUT OF THE PATIENT'S BODY, THE CEREGLIDE 71 WAS FOUND TO BE FLATTENED IN SEVERAL POINTS. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO BREAK IN THE DEVICE INTEGRITY AT THE SITE OF THE DEFECT, LEADING TO POTENTIAL SEPARATION INTO TWO OR MORE SEPARATE PIECES. PRE-SHIPMENT PICTURES ACCOMPANIED THE COMPLAINT FILE SHOWS THE DISTAL TIP OF THE CEREGLIDE WITH TWO COMPRESSED CONDITIONS. ALSO, TWO FLATTENED SECTIONS WERE FOUND IN THE DEVICE. A DAMAGE WAS OBSERVED ON THE EDGE OF THE OF THE DISTAL TIP. ONE KINKED CONDITION WAS NOTED ON THE BODY OF THE CATHETER. THE TOTAL LENGTH OF THE DEVICE WAS 133.50CM. THE PRODUCT WAS RETURNED TO CERENOVUS BLUE LAGOON FOR EVALUATION. VISUAL: THE CATHETER WAS RECEIVED WITH SLIGHT MATERIAL NECKING JUST PROXIMAL TO THE DISTAL MARKER BAND FOR APPROXIMATELY 2 MM. THE INNER PTFE LINER IS DELAMINATED FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A SECTION. THE DELAMINATION EXTENDS TO APPROXIMATELY 5.0 CM FROM THE TIP, THE PROXIMAL END. THERE WERE AREAS ON THE CATHETER THAT WERE FLATTENED OR PARTIALLY FLATTENED. THE FIRST PARTIALLY FLATTENED AREA STARTED AT 17 CM PROXIMAL TO THE DISTAL TIP AND EXTENDED TO 30 CM FROM THE TIP. THE CATHETER WAS COMPLETELY CRUSHED FLAT / KINKED AT 17.5 CM DISTAL TO THE PROXIMAL ID BAND AND PARTIALLY FLATTENED FROM 18 CM THROUGH 21.5 CM FROM THE PROXIMAL ID BAND. AN ATTEMPT WAS MADE TO RECREATE THE DELAMINATION PHENOMENON BY STRETCHING PRODUCT RETAINS FROM LOT 31028722, WHICH WAS A LOT FROM THE ORIGINAL CEREGLIDE PQ/PVE FOR MANUAL MAGIC TOUCH. THE CATHETERS WERE STRETCHED SO THAT THE ORIGINAL ~5CM LONG SECTIONS WERE STRETCHED TO ~13 CM. AFTERWARD DEVICES WERE PASSED THROUGH THE LUMEN. NO DELAMINATION WAS ABLE TO BE CREATED ON THESE NOMINALLY FUSED PRODUCTS. CONCLUSION: THE CATHETER TIP EXPERIENCED TENSION/ELONGATION OF THE DISTAL REGION OF THE CATHETER WHICH CAUSED THE INNER PTFE LINER TO DELAMINATE FROM THE OUTER POLYMER JACKET THROUGHOUT THE 42A MATERIAL. THIS DELAMINATION WAS LESS SEVERE THAN TWO OTHER COMPLAINTS FROM THE NETHERLANDS. BECAUSE OF THE FLATTENED SECTIONS FOUND ON THE CATHETER IN MULTIPLE SPOTS IT IS SUSPECTED THAT THE RHV USED ON THE CATHETER OD WAS TIGHTENED EXCESSIVELY CAUSING STRETCHING OF THE CATHETER WHILE WITHDRAWING FROM THE PATIENT. BASED ON ELONGATION TRIALS ON PRODUCT RETAINS FROM LOT 31028722, A NOMINALLY ASSEMBLED/FUSED PRODUCT DOES NOT DELAMINATE WHEN ELONGATED. THE COMPLAINT PRODUCT IS SUSPECTED TO HAVE A SUB-OPTIMAL FUSE BETWEEN THE PTFE LINER AND THE OUTER POLYMER JACKET. BASED ON THIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. AS PART OF CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. SINCE NO ISSUES WERE IDENTIFIED, NO CAPA ACTIVITY IS REQUIRED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATION: EXERCISE CARE IN HANDLING THE INTERMEDIATE CATHETER TO REDUCE THE CHANCE OF ACCIDENTAL DAMAGE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
IT WAS REPORTED THAT WHILE PULLING A 132CM THE CEREGLIDE 71 (NIC71132C, 31219631), THE TIP OF THE CEREGLIDE 71 SEEMED NOT TO MOVE THOUGH IT WAS BEING PULLED AT HAND. WHEN ALL OF THE PRODUCTS WERE PULLED OUT OF THE PATIENT'S BODY, THE CEREGLIDE 71 WAS FOUND TO BE FLATTENED IN SEVERAL POINTS. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO BREAK IN THE DEVICE INTEGRITY AT THE SITE OF THE DEFECT, LEADING TO POTENTIAL SEPARATION INTO TWO OR MORE SEPARATE PIECES. BASE ON THE PHOTO RECEIVED, DISTAL TIP - ROUGH EDGE WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151638 | 132CM CEREGLIDE 71 CATHETER | CATHETER, ASPIRATION CATHETER | QJP | CERENOVUS, INC. | 31219631 | 10886704085393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ENVI¿ STENT RETRIEVER (NEUROVASC TECHNOLOGIES)| OPTIMO¿ 8F BALLOON GUIDE CATHETER (TOKAI MEDICAL)| SYNCHRO SELECT¿ SUPPORT GUIDEWIRE (STRYKER)| TRAK¿ 21 MICROCATHETER (STRYKER) |