THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
Report
- Report Number
- 2029046-2020-01133
- Event Type
- Malfunction
- Date Received
- August 28, 2020
- Date of Event
- August 3, 2020
- Report Date
- August 3, 2020
- Manufacturer
- BIOSENSE WEBSTER INC.
- Product Code
- LPB
- UDI-DI
- 10846835009200
- PMA / PMN Number
- P030031/S053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
ON 2/17/2021, ADDITIONAL INFORMATION WAS RECEVIED INDICATING A SECOND THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS USED DURING THIS PROCEDURE. AS SUCH, THAT ITEM HAS BEEN ADDED TO FIELD D11. CONCOMITANT MED. PRODUCT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
ON 3/17/2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS A SECOND THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER USED DURING THE PROCEDURE WHICH ALSO HAD AN OVERHEATING HANDLE ISSUE AND ALSO CONTRIBUTED TO THE PROCEDURE CANCELLATION. ANOTHER MEDWATCH HAS BEEN SUBMITTED FOR THAT SUSPECTED DEVICE. AS SUCH, BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MFR # 2029046-2020-01133 FOR PRODUCT CODE D132705 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER). MFR # 2029046-2021-00377 FOR PRODUCT CODE D132705 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WHEREIN A PROCEDURE CANCELLATION OCCURRED INCREASING RISK TO PATIENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER¿S HANDLE WAS OVERHEATING AND PROCEDURE CANCELLATION OCCURRED. PATIENT WAS UNDER GENERAL ANESTHESIA AND TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. IN THE PHYSICIAN¿S OPINION, CANCELLATION OF THE PROCEDURE DID NOT CONTRIBUTE TO A SERIOUS INJURY OF THE PATIENT. DEVICE EVALUATION DETAILS: ON (B)(6) 2020, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITIONS. THE HANDLE WARM TEST WAS PERFORMED, AND THE TEST PASSED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WHEREIN A PROCEDURE CANCELLATION OCCURRED INCREASING RISK TO PATIENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER¿S HANDLE WAS OVERHEATING AND PROCEDURE CANCELLATION OCCURRED. PATIENT WAS UNDER GENERAL ANESTHESIA AND TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. IN THE PHYSICIAN¿S OPINION, CANCELLATION OF THE PROCEDURE DID NOT CONTRIBUTE TO A SERIOUS INJURY OF THE PATIENT. DEVICE INVESTIGATION DETAILS: THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30329824M AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WAS FOUND DURING THE REVIEW. STILL NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #(B)(4).
IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WHEREIN A PROCEDURE CANCELLATION OCCURRED INCREASING RISK TO PATIENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER¿S HANDLE WAS OVERHEATING AND PROCEDURE CANCELLATION OCCURRED. PATIENT WAS UNDER GENERAL ANESTHESIA AND TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. IN THE PHYSICIAN¿S OPINION, CANCELLATION OF THE PROCEDURE DID NOT CONTRIBUTE TO A SERIOUS INJURY OF THE PATIENT. THE CUSTOMER¿S ISSUE OF THE HANDLE OVERHEATING IS NOT MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. THE EVENT HAS BEEN ASSESSED AS MDR REPORTABLE FOR ISSUE OF PROCEDURE CANCELLATION AS THERE IS INCREASED RISK TO THE PATIENT AS A RESULT OF THE PROCEDURE CANCELLATION. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND TRANSSEPTAL PUNCTURE HAD ALREADY BEEN PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 928588 | THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC. | D132705 | 30329824M | 10846835009200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | THMCL SMRTTCH,BI,NAV,TC,D-F,C3 |