VARIPULSE¿ BI-DIRECTIONAL CATHETER
Report
- Report Number
- 2029046-2026-01088
- Event Type
- Malfunction
- Date Received
- April 1, 2026
- Report Date
- April 15, 2026
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- QZI
- PMA / PMN Number
- P240006
- Removal / Correction Number
- 3013300026-01/17/2025-00
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: ZHOU D, LI M, SONG Z, JIANG C, WANG W, TANG R, ZHAO X, LI C, LI S, GUO X, JIA C, NING M, FENG L, WEN D, LIN J, LIU F, LIU T, ZHU H, JIANG Y, GUO P, YUAN L, SANG C, LONG D, DONG J, MA C. IMPACT OF SALINE IRRIGATION ON HAEMOLYSIS, SILENT CEREBRAL LESION INCIDENCE, THERMAL DYNAMICS, AND BUBBLE FORMATION IN PULSED FIELD ABLATION WITH A VARIABLE-LOOP CIRCULAR CATHETER. EUROPACE. 2026 FEB 3;28(2): EUAG005. DOI: 10.1093/EUROPACE/EUAG005. PMID: 41529205; PMCID: PMC12866922. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 REF#: (B)(4).
DURING AN INTERNAL REVIEW ON 01-APR-2026, NOTED CORRECTIONS TO THE 3500A INITIAL. -H11. ADDITIONAL MANUFACTURER NARRATIVE SHOULD HAVE INCLUDED, ¿INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED.¿ -H6. TYPE OF INVESTIGATION SHOULD HAVE INCLUDED, ¿TYPE OF INVESTIGATION NOT YET DETERMINED (B21)¿. -H6. INVESTIGATION FINDINGS WAS PROCESSED AS NO FINDINGS AVAILABLE (C20) AND SHOULD HAVE BEEN PROCESSED AS, ¿RESULTS PENDING COMPLETION OF INVESTIGATION (C21)¿. -H6. INVESTIGATION CONCLUSIONS WAS PROCESSED AS CAUSE NOT ESTABLISHED (D15) AND SHOULD HAVE BEEN PROCESSED AS ¿CONCLUSION NOT YET AVAILABLE (D16)¿. THE INVESTIGATION WAS COMPLETED ON 06-APR-2026. THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: ZHOU D, LI M, SONG Z, JIANG C, WANG W, TANG R, ZHAO X, LI C, LI S, GUO X, JIA C, NING M, FENG L, WEN D, LIN J, LIU F, LIU T, ZHU H, JIANG Y, GUO P, YUAN L, SANG C, LONG D, DONG J, MA C. IMPACT OF SALINE IRRIGATION ON HAEMOLYSIS, SILENT CEREBRAL LESION INCIDENCE, THERMAL DYNAMICS, AND BUBBLE FORMATION IN PULSED FIELD ABLATION WITH A VARIABLE-LOOP CIRCULAR CATHETER. EUROPACE. 2026 FEB 3;28(2):EUAG005. DOI: 10.1093/EUROPACE/EUAG005. PMID: 41529205; PMCID: PMC12866922 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. IT WAS CONFIRMED THAT A TOTAL OF 48 PF APPLICATIONS WERE PERFORMED FOR THE PROCEDURE. AN INCREASED NUMBER OF ABLATIONS (ENERGY APPLICATIONS) DELIVERED DURING THE PROCEDURE MAY BE LINKED TO THE HIGHER-THAN-ANTICIPATED INCIDENCE OF PERI-PROCEDURAL STROKE OR TIA. IN 90% OF THE CASES OF STROKE OR TIA REPORTED TO BWI WORLD-WIDE, PATIENTS RECEIVED A NUMBER OF ABLATIONS GREATER THAN THE MEDIAN NUMBER OF ABLATIONS DELIVERED IN THE INSPIRE STUDY (16 ABLATIONS) AND 60% RECEIVED A NUMBER OF ABLATIONS GREATER THAN THE MEDIAN NUMBER OF ABLATIONS DELIVERED IN THE ADMIRE STUDY (23 ABLATION). MOREOVER, PATIENTS RECEIVED MORE THAN 28 ABLATIONS IN 50% OF THE CASES OF STROKE OR TIA. IT WAS CONFIRMED THAT ABLATION WAS PERFORMED OUTSIDE PULMONARY VEINS. THE USE OF THE VARIPULSE¿ ABLATION CATHETER FOR ABLATIONS BEYOND PULMONARY VEIN ISOLATION MAY BE LINKED TO THE HIGHER-THAN-ANTICIPATED INCIDENCE OF PERI-PROCEDURAL STROKE OR TIA. IN 70% OF THE CASES OF STROKE OR TIA REPORTED TO BWI WORLD-WIDE, PATIENTS RECEIVED ABLATIONS OUTSIDE THE PULMONARY VEINS. THE SAFETY AND EFFECTIVE USE OF THIS DEVICE OUTSIDE OF THE PULMONARY VEINS FOR THE TREATMENT OF ATRIAL FIBRILLATION HAS NOT BEEN CLINICALLY ESTABLISHED AND MAY INCREASE THE RISK OF PATIENT INJURY. 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 REF #: (B)(4).
THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: ZHOU D, LI M, SONG Z, JIANG C, WANG W, TANG R, ZHAO X, LI C, LI S, GUO X, JIA C, NING M, FENG L, WEN D, LIN J, LIU F, LIU T, ZHU H, JIANG Y, GUO P, YUAN L, SANG C, LONG D, DONG J, MA C. IMPACT OF SALINE IRRIGATION ON HAEMOLYSIS, SILENT CEREBRAL LESION INCIDENCE, THERMAL DYNAMICS, AND BUBBLE FORMATION IN PULSED FIELD ABLATION WITH A VARIABLE-LOOP CIRCULAR CATHETER. EUROPACE. 2026 FEB 3;28(2): EUAG005. DOI: 10.1093/EUROPACE/EUAG005. PMID: 41529205; PMCID: PMC12866922. BACKGROUND AND PURPOSE: THOUGH PULSED-FIELD ABLATION (PFA) HAS DEMONSTRATED AN EXCELLENT SAFETY PROFILE IN REDUCING COLLATERAL INJURY TO THE OESOPHAGUS AND PHRENIC NERVE, IT IS STILL ASSOCIATED WITH SPECIFIC EFFECTS, INCLUDING ELECTRODE HEATING, HAEMOLYSIS, AND ELECTROLYSIS DUE TO EXCESSIVE ENERGY DISPERSION. THIS STUDY AIMS TO ASSESS WHETHER SALINE IRRIGATION DURING PFA APPLICATION COULD MITIGATE THESE RISKS. METHODS AND RESULTS: TO COMPREHENSIVELY EVALUATE THE EFFECT OF IRRIGATION WITH THE VARIABLE-LOOP CIRCULAR CATHETER (VLCC), THE FOLLOWING EXPERIMENTS WERE PERFORMED: (I) EX-VIVO POTATO MODEL: TO EVALUATE THE LESION DEPTH, BUBBLE FORMATION, AND THERMAL EFFECTS IN DIFFERENT IRRIGATION REGIMENS; (II) IN VITRO BLOOD POOL AND CARDIAC ABLATION: TO DETERMINE THE HAEMOLYSIS STATUS AND TISSUE TEMPERATURE CHANGE AFTER PFA; (III) IN VIVO SWINE ABLATION (N = 8), AND (IV) CLINICAL RANDOMIZED TRIAL (N = 25): TO COMPARE THE EFFICACY AND SAFETY PROFILE BETWEEN LOW (4 ML/MIN) AND HIGH (30 ML/MIN) FLOW IRRIGATION USING THE VLCC. THOUGH PEAK CORE TEMPERATURES AT 5 MM DEPTH WERE ALL < 50°C UNDER LOW- AND HIGH-IRRIGATION, HIGH IRRIGATION SIGNIFICANTLY MITIGATED THE INSTANT ELECTRODE AND DEEP TISSUE HEATING BOTH IN THE POTATO AND ISOLATED CARDIAC MODELS. EX VIVO POTATO SLICES SHOWED THAT HIGH-FLOW IRRIGATION PRODUCED THE DEEPEST LESION SETS WHEN COMPARED TO LOW-FLOW IRRIGATION (5.94 ± 0.29 MM VS. 5.36 ± 0.33 MM, P = 0.043). ASSESSMENT FROM A HIGH-SPEED CAMERA AND BUBBLE DETECTOR DEMONSTRATED THAT HIGH-FLOW IRRIGATION SIGNIFICANTLY REDUCED THE TOTAL NUMBER OF GASEOUS BUBBLES (54.50 IQR 53.00-56.75 VS. 82.00 IQR 72.00-83.00, P < 0.001) AND ELIMINATED THE OCCURRENCE OF LARGER BUBBLES. THE HIGH-FLOW IRRIGATION GROUP SHOWED A SMALLER INCREASE IN THE LEVEL OF FREE HAEMOGLOBIN IMMEDIATELY AFTER THE PROCEDURE ACROSS THE BLOOD POOL, SWINE, AND CLINICAL MODELS. HAPTOGLOBIN AND LACTATE DEHYDROGENASE LEVELS WERE ALSO ATTENUATED BY HIGH IRRIGATION IN THE IN VIVO SWINE MODEL AND CLINICAL TRIAL. ONE SWINE IN THE LOW-IRRIGATION GROUP DEVELOPED AN ACUTE CEREBRAL LESION (3 MM). THE CLINICAL TRIAL CONFIRMED THAT THE INCIDENCE OF SILENT CEREBRAL LESIONS WAS SIGNIFICANTLY LOWER IN THE HIGH-FLOW IRRIGATION GROUP (16.7% VS. 66.7%, P = 0.036). CONCLUSION: PROPER SALINE IRRIGATION DURING PFA WITH VLCC MAY MITIGATE ELECTRODE-ASSOCIATED HAEMOLYSIS, REDUCE ELECTRODE AND TISSUE TEMPERATURE, LIMIT BUBBLE AGGREGATION, AND BE ASSOCIATED WITH A LOWER INCIDENCE OF SILENT CEREBRAL LESIONS, THE CLINICAL SIGNIFICANCE OF WHICH REMAINS UNCLEAR. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: VARIABLE-LOOP CIRCULAR CATHETER (VLCC) (VARIPULSE, BIOSENSE WEBSTER, IRVINE, CA, USA). OTHER BWI DEVICE(S): TRUPULSE PFA GENERATOR, CARTO 3 3D MAPPING SYSTEM, NGEN (CAPABLE OF CONTROLLING AND RECORDING), INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNKNOWN_VARIPULSE DEVICE(S): PFA PROCEDURE IN SWINE: QTY 1: 1 CASE OF ACUTE CEREBRAL LESION WAS OBSERVED IN ONE SWINE THAT BELONGED TO 4 ML/MIN GROUP. THE LESION DIAMETER WAS 3 MM, LOCATED NEAR THE OCCIPITAL LOBE OF THE BRAIN. INTERVENTION WAS NOT DISCUSSED. QTY 8: ALL PLASMA SAMPLES APPEARANCE SHOWED VISIBLE HAEMOLYSIS IMMEDIATELY AFTER ABLATION AND BECAME CLEAR 24 H AFTER ABLATION. THE IMMEDIATE LEVEL OF FHB CONCENTRATION WAS SIGNIFICANTLY HIGHER IN THE 4 ML/MIN GROUP THAN IN THE 30 ML/MIN GROUP, BOTH AFTER 48 APPLICATIONS (0.46 ± 0.16 G/L VS. 0.24 ± 0.06 G/L, P = 0.047) AND 72 APPLICATIONS (0.60 ± 0.13 G/L VS. 0.36 ± 0.08 G/L, P = 0.021). INTERVENTION WAS NOT DISCUSSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 815539 | 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 | NA | Unknown |