OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
Report
- Report Number
- 2029046-2024-02514
- Event Type
- Malfunction
- Date Received
- July 28, 2024
- Date of Event
- July 2, 2024
- Report Date
- August 27, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DRF
- PMA / PMN Number
- K230253
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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).
THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 14-AUG-2024. THE DEVICE EVALUATION WAS COMPLETED ON 23-AUG-2024. THE DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A BLOOD CLOT ISSUE OCCURRED. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THROMBUS RESIDUES IN ONE SPLINE. AN IRRIGATION TEST WAS PERFORMED AND NO OCCLUSION WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE THROMBUS ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE THROMBUS RESIDUES COULD BE RELATED TO THE USAGE OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CAN NOT BE CONCLUSIVELY DETERMINED. AS PART OF BIOSENSE WEBSTER¿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).
IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A BLOOD CLOT ISSUE OCCURRED. SOMETHING LIKE BLOOD OR A BLOOD CLOT WAS ATTACHED TO THE TIP OF THE OPTRELL PADDLE. AFTER MAPPING WAS PERFORMED WITH OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WAS SWITCHED TO THE SMARTTOUCH SF CATHETER AND THE ABLATION WAS CONDUCTED. AT THE TIMING THAT MAPPING WAS PERFORMED WITH OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AGAIN, THE ISSUE OCCURRED. THE PHYSICIAN WIPED THE CLOT OFF WITH THE HAND, THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES NOR DID THE PHYSICIAN/USER SEE ANY PRODUCT PROBLEM. THE ISSUE WAS RELATED TO THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. SINCE THE ISSUE WAS RELATED TO THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, IT WAS NOT RELATED TO THE GENERATOR NOR THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1775601 | OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER INC | 31255092M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNK GENERATOR| UNK PUMP| UNK_SMART TOUCH UNIDIRECTIONAL SF |