CARTO 3 SYSTEM
Report
- Report Number
- 2029046-2020-00964
- Event Type
- Malfunction
- Date Received
- July 29, 2020
- Date of Event
- July 1, 2020
- Report Date
- July 1, 2020
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DQK
- UDI-DI
- 10846835000870
- PMA / PMN Number
- K133916
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
ON 8/27/2020, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM, AND A MAP SHIFT OCCURRED WITH NO ERROR MESSAGE WITH NO PATIENT MOVEMENT OR CARDIOVERSION. IT WAS REPORTED THAT THERE WAS A NOTICEABLE MAP SHIFT OF 43 MM, THAT WAS NOTED WHILE TRYING TO DELIVER RADIOFREQUENCY (RF) THERAPY. THE BIOSENSE WEBSTER INC. FIELD REPRESENTATIVE STATED THAT THERE WAS NO PATIENT MOVEMENT, NO ERRORS ON THE CARTO 3 SYSTEM, AND NO NOTICEABLE MAP SHIFTS. THEY HAD ALREADY COMPLETED THE FAST ANATOMICAL MAPPING (FAM) MAPPING OF THE LEFT ATRIUM AND WERE STARTING TO ABLATE. THE MAP SHIFT WAS NOTICED WHEN THE PHYSICIAN TRIED TO MAKE CONTACT FOR ABLATION, AND THERE WAS NO CONTACT FORCE AND THE ABLATION DATA WAS "OFF". THE BIOSENSE WEBSTER INC. FIELD REPRESENTATIVE STATED THAT WHEN CONFIRMING WITH THE ULTRASOUND CONTOURS THERE WAS A DEFINITE MAP SHIFT. A NEW MAP WAS CREATED, AND NO FURTHER MAPPING ISSUES WERE PRESENT. HOWEVER, THE CALLER MENTIONED THAT AFTER THEY HAD REMAPPED, THEY CARDIOVERTED THE PATIENT AND THE PHYSICIAN STATED THAT THERE MIGHT HAVE BEEN A NEW MAP SHIFT. THE BIOSENSE WEBSTER INC. FIELD REPRESENTATIVE CONFIRMED NO MAP SHIFT WAS PRESENT IN THE NEW MAP. THERE WERE NO ERRORS DISPLAYED ON THE BIOSENSE WEBSTER INC. EQUIPMENT. IT WAS DISCOVERED AFTER CREATING A FAM MAP WHEN THE PHYSICIAN WAS ABLATING AND THEN REALIZED THAT HIS CONTACT FORCE WAS HIGH, BUT IT DID NOT LOOK LIKE HE WAS TOUCHING THE FAM MAP SHELL. AT THE END OF THE CASE, THE CALLER MEASURED A 43MM SHIFT. HOWEVER, WHEN THE BIOSENSE WEBSTER, INC. FIELD SERVICE REPRESENTATIVE PULLED THE CASE UP, SHE SAID IT WAS LESS THAN THAT, BUT STILL SIGNIFICANT. IT IS POSSIBLE THE CALLER SELECTED AN INTERNAL POINT TO MEASURE FROM BY MISTAKE. THE SHIFT WAS EXCESSIVE, HOWEVER. THERE WAS NO PATIENT MOVEMENT AND NO CARDIOVERSION. AFTER FURTHER DISCUSSION WITH THE PHYSICIAN, IT WAS DETERMINED THAT HE HAD ANESTHESIA CHANGE RESPIRATION¿S FROM 16 BREATHS/MINUTE TO 30 BREATHS/MINUTE JUST BEFORE STARTING TO ABLATE. THIS IS THE NORMAL ROUTINE OF DR. OSORIO, BUT WE DID RECALL THAT HE HAD ALSO POINTED OUT THAT THE RESPIRATORY CURVE LOOKED ABNORMAL ABOUT THIS TIME. THIS WAS DISCUSSED WITH BIOSENSE WEBSTER, INC. FIELD SERVICE REPRESENTATIVE AND SHE THOUGHT THAT THERE MAY HAVE BEEN A PROBLEM WITH THE WORK STATION (WS) AND RESPIRATORY GATING. SHE ORDERED A REPLACEMENT WORK STATION AND WE HAD GREAT CASES ALL WEEK LONG AFTER IT WAS INSTALLED (APPROXIMATELY 5 CASES BETWEEN 2-3 DOCTORS). THE LATTER MAP SHIFT WAS WITH THE SECOND FAM MAP SINCE THERE WAS A CARDIOVERSION DONE AFTER ABLATION WAS COMPLETED. THIS ONE WAS NOTICED WHEN THE A PENTARAY (PR) COULD NOT BE POSITIONED IN THE VEINS AS WELL AS PRIOR TO CARDIOVERSION. THIS WAS NOT AS SIGNIFICANT AND WAS CONSIDERED DUE TO CARDIOVERSION. THERE WAS NO CONSEQUENCE REPORTED. DEVICE EVALUATION DETAILS: COMPANY REPRESENTATIVE SUPPORTED 4 CASES WITH THE SYSTEM, ISSUE DID NOT RETURN. NO PROBLEM WAS FOUND WITH THE WORK STATION, BUT IT WAS REPLACED PER THE PHYSICIAN REQUEST. THERE WERE NO ISSUES IN THE FOLLOWING CASES TOO. THE REPLACED WORK STATION WAS PROCESSED IN QUEST REPAIR CENTER AND WAS FOUND IN GOOD AND USABLE CONDITION. THE REPLACED WORK STATION WAS INVESTIGATED UNDER RMA#902458 BY SUBCONTRACTOR BYNET. NO HARDWARE PROBLEM WAS FOUND. DATA RELATED TO THE REPORTED ISSUE WAS SENT TO THE DEVICE MANUFACTURER FOR INVESTIGATION. IT WAS CONFIRMED THAT THE REPORTED MAP SHIFT WAS CAUSED BY THE PATIENT MOVEMENT, POSSIBLE MOVE OF CATHETER WITHIN THE HEART AND INSUFFICIENT MATRIX IN THE MAPPING AREA. CHANGING THE BREATHING RATE ALONE COULDN'T CAUSE THE REPORTED ISSUE. SYSTEM IS OPERATIONAL. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO 3 SYSTEM # 29173, 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 NUMBER: (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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM, AND A MAP SHIFT OCCURRED WITH NO ERROR MESSAGE WITH NO PATIENT MOVEMENT OR CARDIOVERSION. IT WAS REPORTED THAT THERE WAS A NOTICEABLE MAP SHIFT OF 43 MM, THAT WAS NOTED WHILE TRYING TO DELIVER RADIOFREQUENCY (RF) THERAPY. THE BIOSENSE WEBSTER INC. FIELD REPRESENTATIVE STATED THAT THERE WAS NO PATIENT MOVEMENT, NO ERRORS ON THE CARTO 3 SYSTEM, AND NO NOTICEABLE MAP SHIFTS. THEY HAD ALREADY COMPLETED THE FAST ANATOMICAL MAPPING (FAM) MAPPING OF THE LEFT ATRIUM AND WERE STARTING TO ABLATE. THE MAP SHIFT WAS NOTICED WHEN THE PHYSICIAN TRIED TO MAKE CONTACT FOR ABLATION, AND THERE WAS NO CONTACT FORCE AND THE ABLATION DATA WAS "OFF". THE BIOSENSE WEBSTER INC. FIELD REPRESENTATIVE STATED THAT WHEN CONFIRMING WITH THE ULTRASOUND CONTOURS THERE WAS A DEFINITE MAP SHIFT. A NEW MAP WAS CREATED, AND NO FURTHER MAPPING ISSUES WERE PRESENT. HOWEVER, THE CALLER MENTIONED THAT AFTER THEY HAD REMAPPED, THEY CARDIOVERTED THE PATIENT AND THE PHYSICIAN STATED THAT THERE MIGHT HAVE BEEN A NEW MAP SHIFT. THE BIOSENSE WEBSTER INC. FIELD REPRESENTATIVE CONFIRMED NO MAP SHIFT WAS PRESENT IN THE NEW MAP. THERE WERE NO ERRORS DISPLAYED ON THE BIOSENSE WEBSTER INC. EQUIPMENT. IT WAS DISCOVERED AFTER CREATING A FAM MAP WHEN THE PHYSICIAN WAS ABLATING AND THEN REALIZED THAT HIS CONTACT FORCE WAS HIGH, BUT IT DID NOT LOOK LIKE HE WAS TOUCHING THE FAM MAP SHELL. AT THE END OF THE CASE, THE CALLER MEASURED A 43MM SHIFT. HOWEVER, WHEN THE BIOSENSE WEBSTER, INC. FIELD SERVICE REPRESENTATIVE PULLED THE CASE UP, SHE SAID IT WAS LESS THAN THAT, BUT STILL SIGNIFICANT. IT IS POSSIBLE THE CALLER SELECTED AN INTERNAL POINT TO MEASURE FROM BY MISTAKE. THE SHIFT WAS EXCESSIVE, HOWEVER. THERE WAS NO PATIENT MOVEMENT AND NO CARDIOVERSION. AFTER FURTHER DISCUSSION WITH THE PHYSICIAN, IT WAS DETERMINED THAT HE HAD ANESTHESIA CHANGE RESPIRATION¿S FROM 16 BREATHS/MINUTE TO 30 BREATHS/MINUTE JUST BEFORE STARTING TO ABLATE. THIS IS THE NORMAL ROUTINE OF DR. OSORIO, BUT WE DID RECALL THAT HE HAD ALSO POINTED OUT THAT THE RESPIRATORY CURVE LOOKED ABNORMAL ABOUT THIS TIME. THIS WAS DISCUSSED WITH BIOSENSE WEBSTER, INC. FIELD SERVICE REPRESENTATIVE AND SHE THOUGHT THAT THERE MAY HAVE BEEN A PROBLEM WITH THE WORK STATION (WS) AND RESPIRATORY GATING. SHE ORDERED A REPLACEMENT WORK STATION AND WE HAD GREAT CASES ALL WEEK LONG AFTER IT WAS INSTALLED (APPROXIMATELY 5 CASES BETWEEN 2-3 DOCTORS). THE LATTER MAP SHIFT WAS WITH THE SECOND FAM MAP SINCE THERE WAS A CARDIOVERSION DONE AFTER ABLATION WAS COMPLETED. THIS ONE WAS NOTICED WHEN THE A PENTARAY (PR) COULD NOT BE POSITIONED IN THE VEINS AS WELL AS PRIOR TO CARDIOVERSION. THIS WAS NOT AS SIGNIFICANT AND WAS CONSIDERED DUE TO CARDIOVERSION. THERE WAS NO CONSEQUENCE REPORTED. THE MAP SHIFT DESCRIBED WITH NO ERROR MESSAGE WITH NO PATIENT MOVEMENT OR CARDIOVERSION WAS ASSESSED AS A MDR REPORTABLE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801135 | CARTO 3 SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | BIOSENSE WEBSTER INC | FG540000 | 10846835000870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK_PENTARAY |