OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
Report
- Report Number
- 2029046-2025-01091
- Event Type
- Malfunction
- Date Received
- April 9, 2025
- Report Date
- August 15, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DRF
- PMA / PMN Number
- K230253
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY" LOOKED LIKE IT DID NOT FLUSH PROPERLY, ONCE IT WAS REMOVED FROM THE BODY". THEY HAVE ASKED US TO TEST THE IRRIGATION LUMEN AND IF THE CATHETER IRRIGATION IS WORKING FINE. NO PATIENT CONSEQUENCE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 22-JUL-2025. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST DUE TO THE IRRIGATION TUBE WAS FOUND FOLDED AT THE SHAFT AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE OCCLUSION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE IRRIGATION TUBE FOLDED COULD NOT BE DETERMINED. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
THE INVESTIGATION WAS COMPLETED ON 18-APR-2025. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31371350M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 22-APR-2025. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. PRESSURE BAG USED AT LOW FLOW. OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FLUSHING WAS ¿SUBOPTIMAL¿. NOTICED AND REPORTED FROM THE LAB STAFF AT THE END OF THE CASE. IRRIGATED ABLATION CATHETER USED FOR THE ABLATION, NO ISSUE AT ALL WITH NGEN AND NGEN PUMP. NO ISSUE WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. IN ADDITION, PROVIDED CONCOMITANT PRODUCTS. THEREFORE, UPDATED THE "D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES" SECTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY" LOOKED LIKE IT DID NOT FLUSH PROPERLY, ONCE IT WAS REMOVED FROM THE BODY". THEY HAVE ASKED US TO TEST THE IRRIGATION LUMEN AND IF THE CATHETER IRRIGATION IS WORKING FINE. NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1454626 | OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER INC | 31371350M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNK IRRIGATED ABLATION CATHETER| UNK_NGEN PUMP| UNK_NGEN RF GENERATOR |