CARTO® 3 SYSTEM
Report
- Report Number
- 2029046-2023-03079
- Event Type
- Malfunction
- Date Received
- December 26, 2023
- Date of Event
- November 30, 2023
- Report Date
- December 26, 2023
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DQK
- UDI-DI
- 10846835000870
- PMA / PMN Number
- K213264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. (B)(4).
CORRECTION TO SECTION D4. PRIMARY UDI NUMBER (B)(4) AND TO SECTION G4. PMA/ 510(K) K213264. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).
IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4) ON 19-FEB-2024, IT WAS NOTICED THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE 3500A SUPPLEMENTAL (FOLLOW-UP) MDR # 1 UNDER THE DEVICE INVESTIGATION DETAILS: ¿ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE, "WHEN THE RELATIVE POSITION BETWEEN THE PATCHES REMAINS THE SAME BUT THE POSITION OF THE HEART RELATIVE TO THE BACK PATCHES HAS CHANGED (FOR EXAMPLE, AFTER REPOSITIONING THE PATIENT'S HEAD ON A PILLOW OR MOVING THE PATIENT'S ARM WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS, OR AFTER THE PATIENT IS CARDIOVERTED), THE SYSTEM WILL NOT GIVE A WARNING AND AN INCORRECT MAP (MAP SHIFT) MIGHT BE GENERATED."¿ ADDITIONALLY, THE H6. TYPE OF INVESTIGATION CODES HAVE NOW BEEN ADDED.
IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT THEY GOT A MAP SHIFTED, HOWEVER, THE CARTO®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
IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT THEY GOT A MAP SHIFTED, HOWEVER, THE CARTO® 3 SYSTEM DIDN'T RECOGNIZE AS MAP SHIFT NO ERROR DISPLAYED, AND THE PATIENT DIDN'T MOVE. SHE DID A REMAP AND WHILE DOING IT SHE GOT A HUGE MAP SHIFT (SAW THE MAP SHIFT BECAUSE OF REMAP) PLEASE NOTE THAT THERE'S NO INTERFERENCE WITH ANY MAGNETIC. SHE CHECKED THE BACK PATCHES LOCATION HAVE BEEN MOVED AND SHOWED A DISTANCE FROM THE ORIGINAL BACK PATCHES (ONE BACK PATCH SHOWED 8 MML. 4.5 MML, 6 MML, 8 MML) PLEASE NOTE THAT PATIENT WAS COUGHING DURING THE PROCEDURE BUT WAS NOT RELATED TO MAP SHIFT. NO PATIENT CONSEQUENCES. 30 MINUTES DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2297520 | CARTO® 3 SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | BIOSENSE WEBSTER INC | 10846835000870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |