8.5 FR VARIPULSE CATHETER
Report
- Report Number
- 2029046-2025-01970
- Event Type
- Injury
- Date Received
- June 17, 2025
- Date of Event
- May 21, 2025
- Report Date
- September 5, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- QZI
- PMA / PMN Number
- P240006
- Removal / Correction Number
- 3013300026-01/17/2025-00
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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).
PER INTERNAL REVIEW ON 17-JUN-2025, IT WAS IDENTIFIED THAT THE H7 REMEDIAL ACTION INITIATED TYPE AND THE H9 FDA CORRECTION/ REMOVAL REPORTING NO WERE MISTAKENLY OMITTED FROM THE PREVIOUS INITIAL REPORT. AS A RESULT, THIS FORM HAS BEEN UPDATED WITH THE MISSING INFORMATION. H7: "NOTIFICATION" H9:"3013300026-01/17/2025-001-C" IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ON 24-JUN-2025, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. NO CORONARY SPASMS WERE REPORTED. THERE WERE NO ISSUES WITH THE PATIENT'S CONDITION DUE TO BEING ASYMPTOMATIC. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ON 26-AUG-2025, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS DISCARDED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A 8.5 FR VARIPULSE CATHETER AND THE PATIENT EXPERIENCED SILENT CEREBRAL LESIONS AND POSSIBLE CORONARY SPASMS. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31530674L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. INTERNAL ACTION IS BEING FOLLOWED TO INVESTIGATE NEUROVASCULAR EVENTS WITH VARIPULSE CATHETERS. IMPORTANTLY, THE MECHANISM FOR AN INCIDENCE OF STROKE IS MULTI-FACTORIAL. THE INVESTIGATION ALSO CONCLUDED THAT THE RISK OF NEUROVASCULAR EVENTS MAY INCREASE IF A HIGH NUMBER OF ABLATIONS, STACKING OF ABLATIONS AND/OR ABLATION OUTSIDE OF THE PULMONARY VEINS ARE DELIVERED. THE IFUS (INSTRUCTIONS FOR USE) ARE INSTRUCTIONS THAT PROVIDE DETAILED GUIDANCE ON HOW SAFELY AND EFFECTIVELY USE A MEDICAL DEVICE. IT IS THE PHYSICIAN¿S RESPONSIBILITY TO REVIEW THE PATIENT¿S MEDICAL HISTORY AND MAKE THE BEST-INFORMED DECISION BASED ON ALL AVAILABLE INFORMATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED 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 AN ATRIAL FIBRILLATION ABLATION WITH A 8.5 FR VARIPULSE CATHETER AND THE PATIENT EXPERIENCED SILENT CEREBRAL LESIONS AND POSSIBLE CORONARY SPASMS. PVI (PULMONARY VEIN ISOLATION) WAS PERFORMED WITH VARIPULSE CATHETER, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. AFTER THE PROCEDURE, ALTHOUGH ASYMPTOMATIC, AN MRI (MAGNETIC RESONANCE IMAGING) OF THE BRAIN REVEALED MULTIPLE SCL (SILENT CEREBRAL LESIONS) (CORONARY SPASM) LESIONS. THE PRESENCE OF ASYMPTOMATIC CEREBRAL INFARCTION LESIONS WAS CONFIRMED WITH MRI IMAGING AFTER THE PROCEDURE. THERE WERE NO ISSUES WITH THE PATIENT'S CONDITION DUE TO BEING ASYMPTOMATIC, AND THERE WAS NO EXTENSION OF THE HOSPITALIZATION PERIOD. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS NONE. THERE WERE NO ABNORMALITIES PRIOR TO OR DURING USE OF THE PRODUCT. DURING THE PROCEDURE, THE ACT (ACTIVATED CLOTTING TIME) MANAGEMENT VALUE WAS KEPT 350 SEC OVER. WHEN USING VARIPULSE, THE IRRIGATION FLOW RATE WAS CHANGED TO 30 ML/MIN DURING ABLATION MANUALLY, AND AFTER THE ABLATION COMPLETED, IT WAS RETURNED TO 4 ML/MIN. A TOTAL OF 28 ABLATIONS AND 83 APPLICATIONS WERE CONDUCTED (A TOTAL OF 29 ABLATIONS WERE CONDUCTED IF THE ABLATION ERRORS CAUSED BY ELECTRODE PROXIMITY ARE INCLUDED). TIME FROM PATIENT ENTRY TO ROOM EXIT: 126 MINUTES / FROM SEPTAL PUNCTURE TO PFA (PULSE FIELD ABLATION) COMPLETION: 66 MINUTES / LEFT ATRIAL DWELL TIME: 71 MINUTES / CTI (CAVOTRICUSPID ISTHMUS) LINE WAS ABLATED USING JLL FANTASISTA (ABLATION TIME UNKNOWN). THE PATIENT WAS DIAGNOSED AS AF (ATRIAL FIBRILLATION) WITH ELECTROCARDIOGRAM AT THE REGULAR CHECKUP ON (B)(6) 2025. THE PATIENT CAME TO THE HOSPITAL ON (B)(6) 2025, AND PFA PROCEDURE WAS PERFORMED ON (B)(6), 2025. MEDICATIONS INCLUDED ANTICOAGULANTS (ELIQUIS 10 MG), MICARDIS 40 MG. PAST MEDICAL HISTORY INCLUDES HYPERTENSION. CHADS2VASC SCORE IS 4 POINTS. THERE IS NO HISTORY OF STROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1449827 | 8.5 FR VARIPULSE CATHETER | PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION | QZI | BIOSENSE WEBSTER INC | 31530674L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Life Threatening | 8.5F SHEATH, VIZ SMCURVE, SHORT.| NGEN GENERATOR.| NGEN PUMP.| SOUNDSTAR ECO GE 8F CATHETER. |