CARTO® 3 SYSTEM
Report
- Report Number
- 2029046-2025-00098
- Event Type
- Malfunction
- Date Received
- January 9, 2025
- Date of Event
- December 13, 2024
- Report Date
- February 27, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DQK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON 27-FEB-2025, BWI RECEIVED INFORMATION ON THE MANUFACTURE DATE. ON H4, THE MANUFACTURE DATE WAS UPDATED TO 30-JAN-2011. ADDITIONALLY, THE D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. 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).
PER INTERNAL REVIEW ON 29-JAN-2025, IT WAS DETERMINED THAT THE H6 MEDICAL DEVICE PROBLEM CODE FOR "COMMUNICATION OR TRANSMISSION PROBLEM" (A13) MUST ALSO BE APPLIED TO THIS COMPLAINT. ADDITIONALLY, ON 3-FEB-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: FIELD SERVICE ENGINEER FOLLOWED UP WITH THE CLINICAL ACCOUNT SPECIALIST AND CONFIRMED THAT THE PATIENT INTERFACE UNIT COMMUNICATION ISSUE WAS RESOLVED BY REBOOTING THE PATIENT INTERFACE UNIT. FIELD SERVICE ENGINEER SENT QUOTE FOR PROVIDING SERVICE. DESPITE A NUMBER OF FOLLOW-UPS, THE NECESSARY PURCHASE ORDER WAS NOT PROVIDED BY THE HOSPITAL, TO LET TECHNICAL SERVICE PROVIDE THE SERVICE. IN ADDITION, CLINICAL ACCOUNT SPECIALIST CONFIRMED THAT ALL REPORTED ISSUES WERE NOT REPRODUCED AGAIN. THE SERVICE WAS DECLINED BY THE HOSPITAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO3 SYSTEM SERIAL NUMBER: (B)(6), AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT INVESTIGATION RESULTS WILL BE USED FOR MONITORING AND DETECTING STATISTICAL SIGNALS PER COMPLAINT TRENDING AND SIGNAL DETECTION PROCESS. 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 AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO®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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1377339 | CARTO® 3 SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | FARIWAVE PFA GENERATOR. |