CARTO® 3 SYSTEM
Report
- Report Number
- 2029046-2024-01276
- Event Type
- Malfunction
- Date Received
- April 17, 2024
- Date of Event
- March 22, 2024
- Report Date
- April 17, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DQK
- UDI-DI
- 10846835000870
- PMA / PMN Number
- K231207
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ON 3-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING NO ALERTS WERE SEEN INTRA-PROCEDURE. THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA AND ONLY A CT AND MRI WERE DONE AS FOLLOW UP EXAMINATION TO DETERMINE A DIAGNOSTIC CAUSE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
CORRECTION: ON 30-SEP-2024, IT WAS NOTICED THE INCORRECT PMA/ 510(K) NUMBER OF ¿K133916¿ WAS REPORTED IN THE 3500A INITIAL MEDWATCH REPORT UNDER FIELD G4. THE CORRECT NUMBER HAS NOW BEEN ADDED ¿K231207¿. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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. E1. INITIAL REPORTER PHONE: (B)(6) 20223. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2024-01275 FOR A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. (2) MFR # 2029046-2024-01276 FOR A CARTO® 3 SYSTEM.
ON 29-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS PROCEDURE WAS A PULMONARY VEIN ISOLATION (PVI) + POSTERIOR WALL (PW) ABLATION FOR PERSISTENT ATRIAL FIBRILLATION. 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 A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CEREBROVASCULAR ACCIDENT. IT WAS ALSO REPORTED THERE WAS A MAP SHIFT WITH THE CARTO® 3 SYSTEM THAT WAS USED IN THIS CASE. IT WAS REPORTED THAT AFTER SWITCHING FROM A TRUPULSE GENERATOR TO AN NGEN RF GENERATOR, REMAPPING WAS PERFORMED. HOWEVER, "CONFIDENSE" WASN¿T ADDING POINTS EVEN THOUGH THE FILTERS WERE ALL GREEN. ISSUE WAS QUICKLY RESOLVED BY STOPPING/STARTING COLLECTION AGAIN. ADDITIONALLY, A MAP/GEO SHIFT WAS SEEN AFTER SWITCHING FROM THE TRUPULSE GENERATOR TO AN NGEN RF GENERATOR (NO ALERTS SEEN, AND THE SYSTEM DID NOT ASK TO "LEARN NEW"); PROCEEDED WITH THE CASE BY RECOLLECTING NEW FAM AND POINTS. SIMILAR MAP/GEO SHIFT SEEN AFTER SWAPPING GENERATORS; DIFFERENT DIRECTION OF SHIFT COMPARED TO THE FIRST CASE SO NO CONSISTENCY TO THE MOVEMENT OF SHIFT; PROCEEDED BY RECOLLECTING NEW FAM AND POINTS. NO ERRORS WERE PROVIDED, THE MAP SHIFT CONFIRMED DURING REMAPPING. THERE WAS NO CARDIOVERSION OR PATIENT MOVEMENT BEFORE DETECTING THE SHIFT. DEVICE EVALUATION DETAILS: AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE MAP SHIFT OCCURRED DUE TO CHANGE OF CURRENT DISTRIBUTION ORIGINATED FROM ABLATOR RETURN PATCH INTRODUCTION. USER WAS NOTIFIED. SYSTEM OPERATES AS DESIGNED. THE ISSUE IS RELATED TO USER ERROR. THE SYSTEM IS READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM #11309 WAS REVIEWED. THERE ARE NO ADDITIONAL COMPLAINTS SIMILAR TO REPORTED ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM #11309, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE #(B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CEREBROVASCULAR ACCIDENT. IT WAS ALSO REPORTED THERE WAS A MAP SHIFT WITH THE CARTO® 3 SYSTEM THAT WAS USED IN THIS CASE. IT WAS REPORTED THAT AFTER SWITCHING FROM A TRUPULSE GENERATOR TO AN NGEN RF GENERATOR, REMAPPING WAS PERFORMED. HOWEVER, ¿CONFIDENSE¿ WASN¿T ADDING POINTS EVEN THOUGH THE FILTERS WERE ALL GREEN. ISSUE WAS QUICKLY RESOLVED BY STOPPING/STARTING COLLECTION AGAIN. ADDITIONALLY, A MAP/GEO SHIFT WAS SEEN AFTER SWITCHING FROM THE TRUPULSE GENERATOR TO AN NGEN RF GENERATOR (NO ALERTS SEEN, AND THE SYSTEM DID NOT ASK TO ¿LEARN NEW¿); PROCEEDED WITH THE CASE BY RECOLLECTING NEW FAM AND POINTS. SIMILAR MAP/GEO SHIFT SEEN AFTER SWAPPING GENERATORS; DIFFERENT DIRECTION OF SHIFT COMPARED TO THE FIRST CASE SO NO CONSISTENCY TO THE MOVEMENT OF SHIFT; PROCEEDED BY RECOLLECTING NEW FAM AND POINTS. NO ERRORS WERE PROVIDED, THE MAP SHIFT CONFIRMED DURING REMAPPING. THERE WAS NO CARDIOVERSION OR PATIENT MOVEMENT BEFORE DETECTING THE SHIFT. IT WAS ALSO REPORTED THAT FOLLOWING THE PROCEDURE ON FRIDAY MORNING (B)(6) 2023, THE PATIENT TOOK SOME TIME TO WAKE FROM GENERAL ANESTHETIC. THE PATIENT ALSO WOKE WITH LEFT SIDED WEAKNESS PARTICULARLY IN THEIR HAND. THEY HAD A COMPUTED TOMOGRAPHY (CT), WHICH SHOWED NO ABNORMALITIES BUT BECAUSE SYMPTOMS PERSISTED THEY WERE TRANSFERRED TO A STROKE CENTER (ROYAL LONDON HOSPITAL) WHERE A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED ON (B)(6) 2024. THE MRI SHOWED MANY SMALL EMBOLI AND A LACUNAR INFARCT. THE PATIENT¿S SYMPTOMS RESOLVED AFTER 2 DAYS AND THEY WERE DISCHARGED ON DAY 3 FOLLOWING THE PROCEDURE, HOWEVER, NOT CONSIDERED TO BE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE ADVERSE EVENT IS UNKNOWN. THERE WAS NO EVIDENCE OF CHAR OR BLOOD/THROMBUS/CLOT DURING THE PROCEDURE. NO ERRORS OBSERVED. NO INTERVENTION PROVIDED. AFTER THE MRI, THE SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED WITH NO FURTHER COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1892850 | CARTO® 3 SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | BIOSENSE WEBSTER INC | 10846835000870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | 8.5 FR VARIPULSE CATHETER.| NGEN RF GENERATOR.| TRUPULSE GENERATOR, WW.| UNK_SMART TOUCH BIDIRECTIONAL SF. |