DECANAV ELECTROPHYSIOLOGY CATHETER
Report
- Report Number
- 2029046-2023-01688
- Event Type
- Injury
- Date Received
- August 3, 2023
- Date of Event
- July 5, 2023
- Report Date
- September 1, 2023
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DRF
- UDI-DI
- 10846835008791
- PMA / PMN Number
- K080425
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION PROCEDURE THAT INCLUDED A DECANAV ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT DURING THE PVC CASE, THE PHYSICIAN USED THE SOUNDSTAR CATHETER TO DRAW CONTOURS OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THE PHYSICIAN THEN ADVANCED THE BWI DECA NAV CATHETER INTO THE RVOT. THE PHYSICIAN STATED THAT RESISTANCE WAS FELT WHILE ADVANCING THE DECA NAV CATHETER. THE DECA NAV CATHETER WAS THEN USED TO PERFORM PACE MAPPING AND TO GATHER INTRACARDIAC SIGNALS, ACQUIRING POINTS IN THE RVOT. THE PHYSICIAN THEN MANIPULATED THE SOUNDSTAR CATHETER AND NOTICED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED. THE AMOUNT OF FLUID REMOVED FROM THE PERICARDIAL SPACE IS UNKNOWN. THE PATIENT WAS IN STABLE CONDITION AND NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE CALL. THE DECA NAV CATHETER IS AVAILABLE FOR RETURN. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS RELATED TO ADVANCEMENT OF THE DECA NAV IN THE RVOT. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THIS ADVERSE EVENT AS NON- EMERGENT PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STAYED FOR THREE DAYS OF MONITORING (DRAINED 75CC FROM TAP, WENT TO ICU FOR MONITORING AND DRAIN REMOVED THAT NIGHT). THE PATIENT FULLY RECOVERED. DEVICE EVALUATION DETAILS: THE BIOSENSE WEBSTER (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 08-AUG-2023. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION PROCEDURE THAT INCLUDED A DECANAV ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT DURING THE PVC CASE, THE PHYSICIAN USED THE SOUNDSTAR CATHETER TO DRAW CONTOURS OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THE PHYSICIAN THEN ADVANCED THE BWI DECA NAV CATHETER INTO THE RVOT. THE PHYSICIAN STATED THAT RESISTANCE WAS FELT WHILE ADVANCING THE DECA NAV CATHETER. THE DECA NAV CATHETER WAS THEN USED TO PERFORM PACE MAPPING AND TO GATHER INTRACARDIAC SIGNALS, ACQUIRING POINTS IN THE RVOT. THE PHYSICIAN THEN MANIPULATED THE SOUNDSTAR CATHETER AND NOTICED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED. THE AMOUNT OF FLUID REMOVED FROM THE PERICARDIAL SPACE IS UNKNOWN. THE PATIENT WAS IN STABLE CONDITION AND NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE CALL. THE DECA NAV CATHETER IS AVAILABLE FOR RETURN. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS RELATED TO ADVANCEMENT OF THE DECA NAV IN THE RVOT. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THIS ADVERSE EVENT AS NON- EMERGENT PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STAYED FOR THREE DAYS OF MONITORING (DRAINED 75CC FROM TAP, WENT TO ICU FOR MONITORING AND DRAIN REMOVED THAT NIGHT). THE PATIENT FULLY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280813 | DECANAV ELECTROPHYSIOLOGY CATHETER | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER INC | 31043409M | 10846835008791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Life Threatening| R| H | UNK_C3 EXTERNAL REFERENCE PATCH| UNK_CARTO 3| UNK_SOUNDSTAR |