CARTO® 3 SYSTEM
Report
- Report Number
- 2029046-2024-01798
- Event Type
- Malfunction
- Date Received
- June 3, 2024
- Date of Event
- May 8, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DQK
- UDI-DI
- 10846835000870
- PMA / PMN Number
- K213264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: ON 28-JUN-2024, IT WAS NOTICED THE H6. MEDICAL DEVICE PROBLEM CODE OF "DISPLAY OR VISUAL FEEDBACK PROBLEM (A0902)" WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MEDWATCH REPORT. IT HAS NOW BEEN ADDED. 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 ¿K213264¿. 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. MANUFACTURER'S REF. #(B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A SLIGHT MAP SHIFT OCCURRED. IT WAS REPORTED THAT WHILE DOING A RIGHT-SIDED LATERAL LINE THERE WAS A SLIGHT SHIFT ON THE MAP. THE CALLER STATED THERE WAS A 15 MM SHIFT UP FROM WHERE WAS FIRST ABLATED. THE CARTO 3 SYSTEM SCREEN AND THE BOOM WENT BLACK THEN THE SCREEN CAME BACK UP ON BOTH ON THEIR OWN. THE CARTO® 3 SYSTEM WAS RELOADED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE INVESTIGATION DETAILS: IT WAS CONFIRMED THAT THE MAP SHIFT WAS CAUSED DUE TO FLUORO GOING EXTREME LAO DURING CASE. THE ISSUE IS RELATED TO USER ERROR. IT WAS ALSO REPORTED THAT THE CARTO 3 SYSTEM SCREEN AND THE BOOM WENT BLACK. IT WAS CONFIRMED THAT BOTH SCREENS CAME BACK UP ON THEIR OWN. THE ISSUE WAS RESOLVED BY REPLACING C3 DUAL MONITOR SPLITTER KIT WITH A NEW ONE THAT WAS DELIVERED TO THE ACCOUNT. THE SYSTEM IS READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR AND ASSOCIATED WITH CARTO 3 SYSTEM # (B)(6) WAS REVIEWED. NO SIMILAR ADDITIONAL COMPLAINT WAS FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO 3 SYSTEM # (B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. EXPLANATION OF CODES: INVESTIGATION FINDINGS: ELECTRICAL PROBLEM IDENTIFIED (C02) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO COMPONENT FAILURE (D02) / COMPONENT CODE: HUB (G02021) WERE SELECTED AS RELATED TO THE VIDEO DISPLAY ISSUES. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO USER (D11) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED MAP SHIFT ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
ON 2-FEB-2025, CLARIFICATION WAS PROCESSED FOR THE INVESTIGATION DETAILS PREVIOUSLY REPORTED IN SECTION H11. ADDITIONAL MANUFACTURER NARRATIVE OF THE 3500A SUPPLEMENTAL (FOLLOW-UP) # 4. IT WAS CLARIFIED THAT LOA IS ¿LEFT ANTERIOR OBLIQUE¿. AS SUCH, IT WAS CONFIRMED THAT THE MAP SHIFT CAUSED DUE TO FLUORO GOING THROUGH EXTREME LEFT ANTERIOR OBLIQUE DURING CASE. THE ISSUE IS RELATED TO USER ERROR. 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 CARTO® 3 SYSTEM AND A SLIGHT MAP SHIFT OCCURRED. IT WAS REPORTED THAT WHILE DOING A RIGHT-SIDED LATERAL LINE THERE WAS A SLIGHT SHIFT ON THE MAP. THE CALLER STATED THERE WAS A 15 MM SHIFT UP FROM WHERE WAS FIRST ABLATED. THE CARTO 3 SYSTEM SCREEN AND THE BOOM WENT BLACK THEN THE SCREEN CAME BACK UP ON BOTH ON THEIR OWN. THE CARTO® 3 SYSTEM WAS RELOADED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. INITIALLY THE EVENT WAS ASSESSED AS NOT REPORTABLE SINCE A MAP SHIFT IS A NORMAL OR EXPECTED RESPONSE FROM THE SYSTEM IF THERE IS PATIENT MOVEMENT. HOWEVER, ON 9-MAY-2024, ADDITIONAL INFOMRATION WAS RECEIVED INDICATING THE SHIFT WAS ABOUT A 13 MM SHIFT UP AND IT OCCURRED DURING ABLATION. THERE WERE NO ERROR MESSAGES, NO PATIENT MOVEMENT AND NO CARDIOVERSION DONE ON THE PATIENT. AS SUCH, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION BASED ON THE NEW INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148838 | CARTO® 3 SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | BIOSENSE WEBSTER INC | 10846835000870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN NGEN SYSTEM |