THMCL SMTCH SF BID, TC, D-F
Report
- Report Number
- 2029046-2024-02335
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Report Date
- September 25, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835010183
- PMA / PMN Number
- P030031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BIOSENSE WEBSTER INC. (BWI) SUBMITTED THIS COMPLAINT AS MDR REPORTABLE FOR A SIGNAL LOSS ISSUE; HOWEVER, AFTER FURTHER REVIEW ON 29-AUG-2024, THE EVENT WAS RE-ASSESSED AS NON MDR REPORTABLE. ALTHOUGH THE INCIDENT OF SIGNAL LOSS OCCURRED, IT IS NOT CONFIRMED THAT THE PATIENT'S HEART RHYTHM WAS NOT VISIBLE TO THE OPERATOR ON ALL ELECTROGRAMS (BS AND IC) ON ALL SYSTEMS/MONITORS. AS SUCH, THE CODE OF SIGNAL ARTIFACT (A090801) WAS ADDED AND THE CODE OF COMMUNICATION OR TRANSMISSION PROBLEM (A13) WAS REMOVED UNDER H 6. MEDICAL DEVICE PROBLEM CODE SECTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
CORRECTION: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED PERFORMING A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31290863L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. ADDITIONALLY, THE MANUFACTURED AND EXPIRATION DATES HAVE BEEN PROVIDED. THEREFORE, FIELDS D 4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
D4: UDI: THE MANUFACTURING AND EXPIRATION DATES ARE CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. E 1. INITIAL REPORTER PHONE: (B)(6). 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 A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND DURING ABLATION, HIGH FORCE WAS SHOWING, AND THEY LOST ALL INTRACARDIAC SIGNALS ON THE RECORDING SYSTEM AND THE CARTO. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SIGNAL LOSS WAS OBSERVED ON INTRACARDIAC (IC) AND BODY SURFACE (BS) CHANNELS. THE REPORTER IS UNSURE IF THE PHYSICIAN HAS ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2380118 | THMCL SMTCH SF BID, TC, D-F | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 31290863L | 10846835010183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNK CABLE| UNK_CARTO 3 |