VARIPULSE¿ BI-DIRECTIONAL CATHETER
Report
- Report Number
- 2029046-2026-00637
- Event Type
- Injury
- Date Received
- February 24, 2026
- Date of Event
- February 2, 2026
- Report Date
- May 5, 2026
- 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
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DURING AN INTERNAL REVIEW ON 24-FEB-2026, NOTED THE FOLLOWING CORRECTIONS TO THE 3500A INITIAL. UNDER ¿G3. DATE RECEIVED BY MANUFACTURER¿ WAS PROCESSED AS 02-FEB-2026 IN ERROR. IT SHOULD HAVE BEEN PROCESSED AS 04-FEB-2026. UNDER ¿B5. EVENT DESCRIPTION¿ INCLUDED, ¿THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE VARIPULSE¿ BI-DIRECTIONAL CATHETER (D141201 LOT: UNKNOWN).¿ SHOULD HAVE PROCESSED AS, ¿BWI BECAME AWARE ON 04-FEB-2026 THAT THE PATIENT SUFFERED FROM SEVERAL SMALL STROKES AFTER THE PROCEDURE AND HAVE ASSESSED THE ADVERSE EVENT AS REPORTABLE UNDER THE VARIPULSE¿ BI-DIRECTIONAL CATHETER (D141201 LOT: UNKNOWN). THE AWARENESS DATE FOR THIS RECORD 04-FEB-2026. 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 15-APR-2026, A CORRECTION WAS PROCESSED UNDER THE PRODUCT INVESTIGATION. PLEASE SEE NEW INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. IMPORTANTLY, THE MECHANISM FOR AN INCIDENCE OF STROKE IS MULTI-FACTORIAL. 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 INSTRUCTIONS FOR USE (IFU) 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 THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
DURING AN INTERNAL REVIEW ON 06-APR-2026 NOTED SOME CORRECTIONS ON THE 3500A INITIAL: -UNDER H11. ADDITIONAL MANUFACTURER NARRATIVE, SHOULD NOT HAVE INCLUDED THE FOLLOWING: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. -H6. TYPE OF INVESTIGATION PROCESSED AS DEVICE NOT RETURNED (B17) AND SHOULD HAVE BEEN "TYPE OF INVESTIGATION NOT YET DETERMINED (B21)." -H6. INVESTIGATION FINDINGS PROCESSED AS NO FINDINGS AVAILABLE (C20) AND SHOULD HAVE BEEN "RESULTS PENDING COMPLETION OF INVESTIGATION (C21)." - C6. INVESTIGATION CONCLUSIONS PROCESSED AS CAUSE NOT ESTABLISHED (D15) AND SHOULD HAVE BEEN "CONCLUSION NOT YET AVAILABLE (D16)". THE INVESTIGATION WAS COMPLETED ON 13-MAR-2026. IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED SEVERAL SYMPTOMATIC SMALL STROKES AND REQUIRED PROLONGED HOSPITALIZATION. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED 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 INSTRUCTIONS FOR USE (IFU) ARE INSTRUCTIONS THAT PROVIDE DETAILED GUIDANCE ON HOW SAFELY AND EFFECTIVELY TO 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 THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. 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 A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED SEVERAL SYMPTOMATIC SMALL STROKES AND REQUIRED PROLONGED HOSPITALIZATION. INITIALLY, THE REPORT INDICATED THAT THE VARIPULSE¿ BI-DIRECTIONAL CATHETER (D141201 LOT: 31729960L) HAD A BROKEN BOWDEN WIRE AND IT WAS NOT POSSIBLE TO OPEN AND CLOSE THE CATHETER¿S LOOP ANYMORE. THE SURGERY WAS DELAYED DUE TO THE REPORTED ISSUE FOR 5 MINUTES. A NEW CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 04-FEB-2026 WHICH INDICATED THAT THEY RECEIVED INFORMATION ON 04-FEB-2026 FROM THE PHYSICIAN THAT THE PATIENT SUFFERED FROM SEVERAL SMALL STROKES AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-FEB-2026 WHICH STATED THAT THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED ON 19-FEB-2026. THE NEW CATHETER ¿REPLACEMENT¿ USED AFTER THE CONTRACTION ISSUE WAS THE VARIPULSE¿ BI-DIRECTIONAL CATHETER (D141201 LOT: UNKNOWN). THE ADVERSE EVENT ¿STROKES¿ OCCURRED ON 02-FEB-2026. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT IS IMPOSSIBLE TO SAY WHETHER IT WAS CATHETER EXCHANGE, PROCEDURE RELATED OR PFA. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). COMPUTED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE IMAGING (MRI) SCAN IMAGING WERE PERFORMED TO DIAGNOSE STROKE, AND THE TYPE OF NEUROLOGICAL ISSUE OBSERVED WAS SYMPTOMATIC. THE BRAIN SCANS/MRI SHOWED 2 SMALL LESIONS IN DIFFERENT AREAS OF THE BRAIN. THE PATIENT¿S SYMPTOMS ARE RESOLVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF MONITORING. 18 PFA ABLATIONS WERE PERFORMED WITHIN THE PULMONARY VEINS, AND NONE OUTSIDE THE PULMONARY VEINS. THE ACTIVATED CLOTTING TIME (ACT) DURING PROCEDURE WAS ~350. NO SHEATH EXCHANGE NOTED, AND ONE CATHETER EXCHANGE REPORTED. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. NO EVIDENCE OF CHAR OR BLOOD THROMBUS/CLOT DURING THE PROCEDURE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. NO OBSERVATIONS SUCH AS INTRACARDIAC EXCESSIVE MICROBUBBLES OBSERVED VIA ULTRASOUND, EXCESSIVE IMPEDANCE ERRORS NOTED DURING THE CASE. THE PATIENT¿S RHYTHM DURING ABLATION WAS SINUS RHYTHM (SR). THE TYPE OF ELECTROPHYSIOLOGY PROCEDURE BEING PERFORMED WAS NEW PROCEDURE. PRE-ABLATION THROMBUS CHECK WAS PERFORMED. THE PATIENT DID NOT HAVE ANY ANATOMICAL ABNORMALITIES. NO ABLATION STACKING OCCURRED FOR THIS PROCEDURE. THE IRRIGATION RATE USED DURING THIS PROCEDURE WAS 30ML/MIN. A TRUPULSE GENERATOR WAS USED FOR THE PROCEDURE. THE ¿BROKEN BOWDEN WIRE (IT WAS NOT POSSIBLE TO OPEN AND CLOSE THE CATHETER¿S LOOP ANYMORE) UNDER THE VARIPULSE¿ BI-DIRECTIONAL CATHETER (D141201 LOT: 31729960L) WAS ASSESSED AS NOT MDR REPORTABLE. SINCE THE LOOP CONTRACTION MECHANISM IS NOT WORKING PROPERLY, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE VARIPULSE¿ BI-DIRECTIONAL CATHETER (D141201 LOT: UNKNOWN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606539 | VARIPULSE¿ BI-DIRECTIONAL CATHETER | PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION | QZI | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |