8.5 FR VARIPULSE CATHETER
Report
- Report Number
- 2029046-2025-01175
- Event Type
- Injury
- Date Received
- April 22, 2025
- Date of Event
- March 23, 2025
- Report Date
- October 9, 2025
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- QZI
- UDI-DI
- 10846835025460
- PMA / PMN Number
- P240006
- Removal / Correction Number
- 3013300026-01/17/2025-00
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- 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).
ON 6-MAY-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. ADDITIONALLY, ON 28-MAY-2025, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE OBSERVED INTRACARDIAC MICROBUBBLES WERE CONSIDERED EXCESSIVE. AS A RESULT, THE H6 MEDICAL DEVICE PROBLEM CODE FOR "AIR/GAS IN DEVICE (A1415)" HAS BEEN APPLIED TO THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
PER INTERNAL REVIEW ON 17-SEP-2025, THE PRODUCT INVESTIGATION WAS UPDATED WITH THE FOLLOWING INFORMATION: AN INTERNAL ACTION IS BEING FOLLOWED TO INVESTIGATE NEUROVASCULAR EVENTS WITH VARIPULSE CATHETERS, AS PREVIOUS INVESTIGATIONS 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. 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 5-JUN-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A 8.5 FR VARIPULSE CATHETER AND THE PATIENT EXPERIENCED CEREBRAL INFARCTIONS. ON (B)(6) 2025, AN ABLATION PROCEDURE WAS PERFORMED, AIMED AT ISOLATING THE PULMONARY VEINS FOR THE TREATMENT OF ATRIAL FIBRILLATION. DURING THE PROCEDURE, A VARIPULSE CATHETER WAS USED. THE ELECTROPHYSIOLOGIST ADVANCED THE CATHETER, CREATED THE ELECTRO ANATOMICAL MAP, AND THEN REACHED THE PULMONARY VEINS TO POSITION THE CATHETER FOR ABLATION. SUBSEQUENTLY, THE ELECTROPHYSIOLOGIST PERFORMED ABOUT 23 ABLATIONS ON THE FOUR PULMONARY VEINS. DURING THE PROCEDURE, THE ELECTROPHYSIOLOGIST ALSO ADVANCED AN INTRACARDIAC ECHOCARDIOGRAPHY CATHETER, AND WHEN HE EXAMINED THE ABLATION AREA THROUGH THE ECHO, HE OBSERVED A STREAM OF AIR MICROBUBBLES DURING SOME OF THE ABLATIONS. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED FOLLOWING J&J MEDTECH 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 NUMBER 31517575L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE ADVERSE EVENT OR THE EXCESSIVE MICROBUBBLES REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. REGARDING THE BUBBLES ISSUE, THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING RECOMMENDATIONS: ¿USING STANDARD ASEPTIC TECHNIQUE, FLUSH THE CATHETER AND IRRIGATION TUBING SET TO REMOVE AIR BUBBLES. TO VERIFY PATENCY THROUGHOUT THE CATHETER, HOLD THE CATHETER WITH THE LOOP FACING DOWNWARD AND PARALLEL TO THE FLOOR, FLUSH THE CATHETER, AND VERIFY THAT SALINE FLOWS FROM EACH ELECTRODE. HOLD THE CATHETER WITH THE LOOP FACING UPWARD AND USE STANDARD ASEPTIC TECHNIQUE TO FLUSH AIR BUBBLES FROM THE CATHETER AND THE TUBING. J&J MEDTECH INVESTIGATED POTENTIAL DEVICE-, PROCEDURE-, AND PATIENT-RELATED FACTORS. THIS INVESTIGATION CONCLUDED THAT THE DEVICES PERFORM AS INTENDED, THAT THERE ARE NO DIFFERENCES IN PERFORMANCE AMONG THE AVAILABLE VARIPULSE¿ SYSTEM CONFIGURATIONS WORLDWIDE, AND THERE IS NO CAUSAL RELATIONSHIP THAT HAS EMERGED TO EXPLAIN CVA (CEREBROVASCULAR ACCIDENT) CASE. IMPORTANTLY, THE MECHANISM FOR AN INCIDENCE OF STROKE OR TIA (TRANSIENT ISCHEMIC ATTACK) IS MULTI-FACTORIAL. AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AN INTERNAL ACTION WAS INITIATED TO INVESTIGATE NEUROVASCULAR EVENTS WITH VARIPULSE CATHETERS. 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 CEREBRAL INFARCTIONS. ON (B)(6) 2025, AN ABLATION PROCEDURE WAS PERFORMED, AIMED AT ISOLATING THE PULMONARY VEINS FOR THE TREATMENT OF ATRIAL FIBRILLATION. DURING THE PROCEDURE, A VARIPULSE CATHETER WAS USED. THE ELECTROPHYSIOLOGIST ADVANCED THE CATHETER, CREATED THE ELECTRO ANATOMICAL MAP, AND THEN REACHED THE PULMONARY VEINS TO POSITION THE CATHETER FOR ABLATION. SUBSEQUENTLY, THE ELECTROPHYSIOLOGIST PERFORMED ABOUT 23 ABLATIONS ON THE FOUR PULMONARY VEINS. DURING THE PROCEDURE, THE ELECTROPHYSIOLOGIST ALSO ADVANCED AN INTRACARDIAC ECHOCARDIOGRAPHY CATHETER, AND WHEN HE EXAMINED THE ABLATION AREA THROUGH THE ECHO, HE OBSERVED A STREAM OF AIR MICROBUBBLES DURING SOME OF THE ABLATIONS. THE ELECTROPHYSIOLOGIST SUCCESSFULLY COMPLETED THE PROCEDURE. THE VENOUS ISOLATION WAS SUCCESSFULLY ACHIEVED. THE PATIENT FELT WELL, WITH NO SYMPTOMS ON THE DAY OF THE PROCEDURE OR AFTERWARD. DUE TO THE MICROBUBBLES, AND DESPITE THE PATIENT FEELING WELL, THE ELECTROPHYSIOLOGIST PROACTIVELY DECIDED TO SEND HER FOR A BRAIN MRI (MAGNETIC RESONANCE IMAGING). THE MRI WAS PERFORMED ON (B)(6) 2025. AFTER THE MRI, THE ELECTROPHYSIOLOGIST REPORTED "6 BRAIN INFARCTIONS WITHOUT SYMPTOMS. IN DWI/FLAIR IMAGING, THERE ARE HYPERINTENSE FOCAL FOCI, IN PART HYPOINTENSE ON ADC (APPARENT DIFFUSION COEFFICIENT) AS AN EXPRESSION OF THEIR ACUTE AGE) IN THE FRONTAL SUBCORTICAL WHITE MATTER BILATERAL, MORE ON THE LEFT SIDE, RIGHT PERITRIGONAL, TEMPORAL, AND OCCIPITAL ON THE LEFT. FRONTAL ON THE RIGHT. THESE LESIONS LIKELY REPRESENT SCL FOCI. IN THE FLAIR SEQUENCE, ABNORMAL SIGNAL FOCI ARE SHOWN IN THE WHITE MATTER ¿ THE SUBCORTICAL AND DEEP IN THE HEMISPHERE, BILATERAL. CHRONIC LACUNAR INFARCTS ALONG THE DEEP POSTERIOR WATERSHED LINE BILATERALLY (MORE THAN 3 BILATERALLY). IN THE LEFT THALAMUS, THERE IS A CHRONIC LACUNAR INFARCT. THERE WAS NO INTERVENTION, ONLY FOLLOW UP. THE PATIENT FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS BWI PRODUCT MALFUNCTION AND PROCEDURE. PROCEDURAL ACT (ACTIVATED CLOTTING TIME) WAS ABOVE 350.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1291687 | 8.5 FR VARIPULSE CATHETER | PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION | QZI | BIOSENSE WEBSTER INC | 31517575L | 10846835025460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Other | TRUPULSE GENERATOR. |