132CM CEREGLIDE 71 CATHETER
Report
- Report Number
- 3007628272-2024-00047
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Date of Event
- September 3, 2024
- Report Date
- October 15, 2024
- Manufacturer
- CERENOVUS, INC.
- Product Code
- NRY
- UDI-DI
- 10886704085393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 19-SEP-2024. [ADDITIONAL INFORMATION]: ON 19-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE LOT NUMBER ASSOCIATED WITH THE EMBOGUARD DEVICE USED COULD NOT BE OBTAINED; HOWEVER, THE FOLLOWING LOT NUMBERS WERE PRESENT AT THE ACCOUNT AT THE TIME OF THE EVENT: 8968836, 8977757, 8989409, 8996345, AND 9125054. PER THE INFORMATION, THE TARGET VESSEL OF THE PROCEDURE WAS THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE MICROCATHETER USED WAS NOT A CERENOVUS BRAND; FURTHER INFORMATION COULD NOT BE OBTAINED ON THE SPECIFIC BRAND OF THE CONCOMITANT MICROCATHETER. THE INFORMATION INDICATED THAT ONE PASS WAS MADE WITH THE CEREGLIDE 71 INTERMEDIATE CATHETER; THE CEREGLIDE 71 WAS NOT REPLACED. THE SAME EMBOTRAP III AND THE SAME EMBOGUARD WERE USED TO COMPLETE THE PROCEDURE. PER THE ADDITIONAL INFORMATION, ASIDE FROM THE RESISTANCE REPORTED WHEN THE CEREGLIDE 71 INTERMEDIATE CATHETER WAS INSERTED INTO THE EMBOGUARD, THERE WERE NO PERFORMANCE ISSUE / MALFUNCTION ASSOCIATED WITH THE EMBOGUARD. THERE WAS NO PERFORMANCE ISSUE / DEVICE MALFUNCTION ASSOCIATED WITH THE EMBOTRAP III DEVICE. NO FURTHER INFORMATION CAN BE OBTAINED. UPDATED SECTIONS: B.4, G.3, G.6, H.2, AND H.11. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 08-OCT-2024. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.11. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. 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. PRE-SHIPMENT PHOTOS OF THE CEREGLIDE WERE ALSO RECEIVED ON 11-SEP-2024. THE PHOTOS WERE REVIEWED BY THE PRODUCT ANALYSIS TEAM AND THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: THE PRE-SHIPMENT PHOTOS WERE ATTACHED TO THE COMPLAINT. TWO KINKS CAN BE OBSERVED AT THE DISTAL END OF THE CATHETER. THE FIRST KINK WAS FOUND AT 18.5CM FROM THE DISTAL END; THE SHAFT WAS STRETCHED. IN THE KINKED SECTION, THE INNER MESH WAS PROTRUDING AT THE SURFACE OF THE SHAFT, AND THERE WAS A TEAR ON THE SHAFT COATING. THE SECOND KINK WAS FOUND AT 32.5 CM FROM THE DISTAL END. NO TEARS ON THE COATING WERE NOTED. NO ABNORMALITIES IN APPEARANCE WERE OBSERVED IN OTHER PARTS OF THE PRODUCT. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31287913) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE ISSUE REPORTED REGARDING A HOLE IN THE SHAFT WAS CONFIRMED BASED ON THE TEAR OBSERVED ON THE SHAFT. THIS COULD BE THE RESULT OF THE STRETCHED CONDITION OBSERVED ON THE DISTAL END OF THE CATHETER; HOWEVER, THIS REMAINS SPECULATIVE. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTOS PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. THE KINKED AREAS OBSERVED ON THE SHAFT WERE NOT ORIGINALLY REPORTED; THESE COULD BE THE RESULT OF POST HANDLING OF THE DEVICE; THEREFORE, THEY ARE NOT CONSIDERED RELATED TO THE ISSUE REPORTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: PC-(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE CEREGLIDE 71 INTERMEDIATE CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. TWO KINKS WERE FOUND ON THE DEVICE. THE FIRST AT 18.50 CM AND THE SECOND AT 32.50 CM. ALL MEASUREMENTS WERE TAKEN FROM THE DISTAL END OF THE DEVICE. THE SHAFT WAS FOUND SLIGHTLY STRETCHED. THESE OBSERVATIONS ARE CONSISTENT WITH THE FINDINGS OBSERVED ON THE PRE-SHIPMENT PHOTOS. NO ABNORMALITIES WERE OBSERVED ON THE REST OF THE DEVICE. THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) OF THE CATHETER WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. FUNCTIONAL TEST WAS PERFORMED. THE RETURNED DEVICE WAS FLUSHED USING A LAB SAMPLE SYRINGE AND NO WATER LEAKAGE WAS OBSERVED FROM AN UNINTENDED LOCATION. AS THE FUNCTIONAL TEST WAS PERFORMED WITHOUT ISSUES AND THE DEVICE INTEGRITY WAS FOUND NOT COMPROMISED, THE ISSUE REGARDING A CATHETER BEING CRACKED COULD NOT BE CONFIRMED. HOWEVER, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31287913) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO THE CAUSE OF THE EVENT REPORTED, THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING PRECAUTIONS: - CAREFULLY INSPECT ALL DEVICES PRIOR TO USE. VERIFY SIZE, LENGTH, AND CONDITION ARE SUITABLE FOR THE SPECIFIC PROCEDURE AND PATIENT. DO NOT USE A DEVICE THAT HAS BEEN DAMAGED IN ANY WAY; REPLACE WITH ANOTHER INTERMEDIATE CATHETER. A DAMAGED DEVICE MAY CAUSE COMPLICATIONS. - DO NOT ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE DEVICE AGAINST RESISTANCE COULD DAMAGE THE DEVICE OR CAUSE PATIENT INJURY. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.11. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING A CEREBRAL ARTERY OCCLUSION, A CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132C / 31287913) WAS USED. AN EMBOGUARD BALLOON CATHETER (CATALOG / LOT# UNKNOWN) AND A 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / LOT# UNKNOWN) WERE ALSO USED AS STANDARD PROCEDURE. IT WAS REPORTED THAT WHEN THE CEREGLIDE 71 INTERMEDIATE CATHETER WAS PULLED, BLOOD LEAK WAS OBSERVED. A HOLE WAS FOUND IN THE CATHETER WALL ¿AT THE COLOR CHANGED (AT ANGLE CUT OR PROXIMAL).¿ THE PHYSICIAN COMMENTED THAT ¿THERE WAS SOME RESISTANCE WHEN THE CEREGLIDE 1 WAS INSERTED INTO THE EMBOGUARD, WHICH [THE PHYSICIAN] WAS NOT SURE IF IT [WAS] DUE TO THE HOLE IN THE CATHETER WALL. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ON 11-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; NO FUTURE PROCEDURE IS PLANNED. THE INFORMATION ALSO CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. PRE-SHIPMENT PHOTOS OF THE CEREGLIDE WERE ALSO RECEIVED ON 11-SEP-2024. THE PHOTOS WILL UNDERGO REVIEW BY THE PRODUCT ANALYSIS TEAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2526627 | 132CM CEREGLIDE 71 CATHETER | CATHETER, THROMBUS RETRIEVER | NRY | CERENOVUS, INC. | 31287913 | 10886704085393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | EMBOTRAP III 5 MM X 37 MM| UNKNOWN EMBOGUARD BALLOON |