132CM CEREGLIDE 71 CATHETER
Report
- Report Number
- 3007628272-2024-00039
- Event Type
- Malfunction
- Date Received
- July 9, 2024
- Date of Event
- May 22, 2024
- Report Date
- September 11, 2024
- Manufacturer
- CERENOVUS, INC.
- Product Code
- NRY
- UDI-DI
- 10886704085393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). A VIDEO WAS ADDED TO THE COMPLAINT FILE WHICH SHOWS THE TIP OF TWO CEREGLIDE CATHETERS. THE DEVICES WERE NOTED TO BE FLUSHED AND THEN, WATER LEAKAGE WAS OBSERVED IN THE RIGHT CATHETER FROM THE BRAIDED MESH SECTION. DUE TO THE DISTANCE FROM WHICH THE VIDEO WAS RECORDED, NO ADDITIONAL DAMAGES COULD BE NOTED ON THE DEVICE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH FOR FURTHER EVALUATION. A NON-STERILE 132CM CEREGLIDE 71 CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND ONE (1) COMPRESSED CONDITION WAS NOTED AT 2CM FROM THE DISTAL END OF THE CATHETER. THE INTERNAL COATING OF THE TIP WAS NOTED TO BE DELAMINATED, AND THE MESH OF THE TIP WAS SLIGHTLY STRETCHED. THE CATHETER WAS FLUSHED USING A LAB-SAMPLE SYRINGE, AND THE WATER WAS LEAKING AT 4.5 CM FROM THE DISTAL END. THE DISTAL TIP WAS INSPECTED UNDER MAGNIFICATION AND A CUT WAS NOTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE TRACKING DIFFICULTY DOCUMENTED IN THE COMPLAINT COULD NOT BE DUPLICATED IN THE LABORATORY SETTING SINCE SUCH ISSUE IS MOST RELATED TO THE PATIENT ANATOMY, DEVICE MANIPULATION, AND DEVICE SELECTION; HOWEVER, THE MULTIPLE DAMAGES FOUND IN THE RETURNED CATHETER APPEARED TO BE A TRANSLATION OF THE DIFFICULTY WHILE MANEUVERING THE DEVICE. THE ISSUES REPORTED REGARDING A CUT AND KINKED CONDITIONS ON THE DISTAL TIP OF THE CATHETER CAN BE CONFIRMED BASED ON THESE; HOWEVER, FACTORS NOT DESCRIBED IN THE INFORMATION PROVIDED, SUCH AS PATIENT¿S ANATOMY, DEVICE MANIPULATION, AND OPERATOR¿S TECHNIQUE, MAY HAVE CONTRIBUTED TO THE ISSUE ENCOUNTERED. ACCORDING TO THE RISK DOCUMENTATION A DAMAGED CATHETER IS A POTENTIAL ISSUE THAT CAN OCCUR DURING WITHDRAWAL OF CATHETER. WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED, HOWEVER, GIVEN THE BROAD SEQUENCE OF EVENTS, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS RELATED TO A MANUFACTURING ISSUE. THE DELAMINATION OF THE INTERNAL COATING OF THE TIP WAS NOT ORIGINALLY REPORTED; THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED. IT IS SUGGESTED THAT THIS CONDITION COULD BE THE RESULT OF THE POST-HANDLING OF THE DEVICE; THEREFORE, THIS IS NOT CONSIDER RELATED TO THE ISSUE REPORTED. AS PART OF JOHNSON & JOHNSON MEDTECH 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 SUCH AS CATHETER STRETCHING AND KINKING FROM LEAVING THE FACILITY. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CAPA ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: 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.
PRODUCT COMPLAINT #: (B)(4). SECTION D2B: PROCODE IS NRY/QJP. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT #(B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION H3 - THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A VIDEO WAS ADDED TO THE COMPLAINT FILE WHICH SHOWS THE TIP OF TWO CEREGLIDE CATHETERS. THE DEVICES WERE NOTED TO BE FLUSHED AND THEN, WATER LEAKAGE WAS OBSERVED IN THE RIGHT CATHETER FROM THE BRAIDED MESH SECTION. DUE TO THE DISTANCE FROM WHICH THE VIDEO WAS RECORDED, NO ADDITIONAL DAMAGES COULD BE NOTED ON THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REGARDING A CATHETER BEING KINKED AND SUBSEQUENTLY PUNCTURED WAS CONFIRMED BASED ON THE WATER LEAKAGE OBSERVED, HOWEVER, THE ISSUE REPORTED REGARDING TRACKING DIFFICULTIES COULD NOT BE EVALUATED BASED ON THE VIDEO PROVIDED SINCE THIS ISSUE IS MOST SPECIFIC TO THE PATIENT AT THE PROCEDURE TIME . THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE VIDEO 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. THERE IS NO EVIDENCE TO SUGGEST THE REPORTED THROMBOEMBOLISM WAS RELATED TO THE USE OF THE CEREGLIDE71 INTERMEDIATE CATHETER. PER THE EVENT DESCRIPTION, THE DEVICE WAS NOT ADVANCED TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND WAS LEFT AT THE INTERNAL CAROTID ARTERY (ICA) DURING THE RETRIEVAL ATTEMPT. A HOLE OR SLASH IN THE BODY OF THE CATHETER COULD LEAD TO A DIRECTED JET OF CONTRAST, RESULTING IN DISSECTION, PERFORATION, OR OTHER VESSEL DAMAGE. THERE IS ALSO THE POTENTIAL TO INJECT AIR, WHICH COULD RESULT IN ISCHEMIA OR INFARCT. HOWEVER, THIS EVENT DID NOT RESULT IN PATIENT HARM; THEREFORE, THIS EVENT DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. CATHETER KINKING/DAMAGE DURING CLINICAL USE IS A KNOWN AND COMMON OCCURRENCE OCCURRING DURING ANGIOGRAPHY AND IS TYPICALLY RELATED TO ANATOMY, TECHNIQUE, SKILL, AND VESSEL TORTUOSITY. THE INSTRUCTIONS FOR USE CAUTIONS USERS TO INSPECT FOR KINKS AND BENDS, OR OTHER SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. IF THE OPERATOR ENCOUNTERS KINKING OR DAMAGE DURING USE, THEY ARE CLINICALLY TRAINED TO IMMEDIATELY DISCONTINUE MANIPULATIONS AND REMOVE THE PRODUCT. THEREFORE, THE POTENTIAL FOR PATIENT INJURY/DEATH OCCURRING AS A RESULT OF KINKING OR BEND TYPE DAMAGE IS REMOTE. DIFFICULTY TRACKING A CATHETER THROUGH THE VASCULATURE IS A KNOWN PROCEDURAL OCCURRENCE. THE CONSEQUENCES OF TRACKING DIFFICULTY OCCURRING DURING CLINICAL USE OF THE DEVICE ARE USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. TRACKING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT ANATOMY, OPERATOR TECHNIQUE, AND APPROPRIATE DEVICE SELECTION. THEREFORE, THE POTENTIAL FOR PATIENT INJURY/DEATH OCCURRING AS A RESULT OF ANY TRACKING DIFFICULTY IS REMOTE. BASED ON THIS INFORMATION, THIS EVENT DOES NOT MEET US FDA REPORTING CRITERIA AS A SERIOUS INJURY. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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.
IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A 132CM CEREGLIDE 71 CATHETER (NIC71132C/ 31281883) WAS USED FOR A MECHANICAL THROMBECTOMY OF THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) FOR AN ACUTE ISCHEMIC STROKE. DURING THE PROCEDURE, THE USER REPORTED CEREGLIDE71 - TRACKING DIFFICULTY, KINKING/BENDING WHILE IN PATIENT, AND A PUNCTURE/CUT TO THE CEREGLIDE71 BODY/SHAFT UPON REMOVING THE DEVICE FROM THE PATIENT. DUE TO THE TRACKING DIFFICULTY, THE CEREGLIDE71 WAS NOT ABLE TO BE ADVANCED TO THE TARGET LOCATION AND WAS LEFT AT THE INTERNAL CAROTID ARTERY (ICA). THE SOLITAIRE STENT-RETRIEVER (MEDTRONIC) WAS USED TO RETRIEVE THE TARGET CLOT, HOWEVER, A PART OF THE THROMBUS MIGRATED TO ¿PERIPHERAL ON THE DISTAL SIDE," AND IMMEDIATELY RETRIEVED BY VECTA46 (STRYKER) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. UPON WITHDRAWING THE CEREGLIDE71 FROM THE PATIENT¿S BODY, THE DEVICE WAS FOUND TO BE DAMAGED. WHEN FLUSHING THE CATHETER OUTSIDE OF THE PATIENT, A LEAK OF NORMAL SALINE SOLUTION WAS FOUND AT 4-5CM FROM THE CATHETER TIP. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1 FOR ACUTE ISCHEMIC STROKE. THE PROCEDURE WAS INITIATED BY COMBINED TECHNIQUE WITH USING SOLITAIRE, TRAK21 AND THE CEREGLIDE 71. WHEN THE CEREGLIDE 71 WAS DELIVERED, RESISTANCE WAS FELT NEAR IC-TOP AND COULD NOT BE ADVANCED, SO THE CEREGLIDE 71 WAS PLACED AT THAT POINT. THEN, THE SOLITAIRE CROSSED THE LESION AND THROMBUS RETRIEVAL WAS PERFORMED. DURING THROMBUS RETRIEVAL, A PART OF THROMBUS MIGRATED TO PERIPHERY AND IMMEDIATELY RETRIEVED BY VECTA46. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING THROMBUS RETRIEVAL, AFTER 1PASS, THE CEREGLIDE WAS FOUND TO BE DAMAGED UPON WITHDRAWING FROM THE PATIENT¿S BODY. WHEN FLUSHING THE CATHETER OUTSIDE OF THE PATIENT, A LEAK OF NORMAL SALINE SOLUTION WAS FOUND AT 4-5CM FROM THE CATHETER TIP. THE CATHETER WAS THOUGHT TO HAVE A HOLE, WHICH WAS SUSPECTED TO BE LED BY KINK. POST-PROCEDURE CHANGES IN THE PATIENT: THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. CONTINUOUS FLUSH WAS DONE. THE LESION WAS MIDDLE CEREBRAL ARTERY M1. ANOTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER (STRYKER).¿.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1459702 | 132CM CEREGLIDE 71 CATHETER | CATHETER, ASPIRATION CATHETER | NRY | CERENOVUS, INC. | 31281883 | 10886704085393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | AXS VECTA® 46 INTERMEDIATE CATHETER (STRYKER).| SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC).| TRAK¿ 21 MICROCATHETER (STRYKER). |