VARIPULSETM CATHETER
Report
- Report Number
- 2029046-2025-02160
- Event Type
- Injury
- Date Received
- July 2, 2025
- Date of Event
- June 4, 2025
- Report Date
- September 12, 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
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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).
DURING AN INTERNAL REVIEW ON 03-JUL-2025, NOTED A CORRECTION TO THE 3500A INITIAL AS SHOULD HAVE PROCESSED H7. REMEDIAL ACTION INITIATED TYPE AND H9. FDA CORRECTION/ REMOVAL REPORTING NO. FIELDS. THEREFORE, PROCESSED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON 03-JUL-2025. IRRIGATION RATE FOR THIS PROCEDURE HAS BEEN CONFIRMED AS 15ML/MIN. 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 VARIPULSETM CATHETER AND THE PATIENT EXPERIENCED STROKE. THE DEVICE EVALUATION WAS COMPLETED ON 18-AUG-2025. 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 INVESTIGATION WAS PERFORMED WITH THE FOLLOWING SUMMARY: 1. WORKFLOW INVOLVED A NORMAL RANGE OF ABLATIONS (24 COMPLETE). 2. WORKFLOW NORMAL, NO MAJOR CONCERNS WITH ABLATION LOCATIONS OR TIMING. CLEAN PVI ONLY WITH GOOD CATHETER MOVEMENT. NORMAL # OF CATHETER EXCHANGES: OCTARAY TO MAP, VP TO ABLATE. 3. BASELINE IMPEDANCE WAS WITHIN NORMAL RANGE, A FEW OHM BELOW THE CLINICAL AVERAGE. CURRENT CORRESPONDS WELL. NO CLEAR CARTO/GENERATOR LEVEL CONTRIBUTORS TO STUDY ADVERSE EVENT. AN INTERNAL CORRECTIVE 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 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A VARIPULSETM CATHETER AND THE PATIENT EXPERIENCED STROKE. AFTER THE CASE, THE PATIENT SUFFERED A STROKE. THE DAY AFTER THE PROCEDURE, THE PATIENT WENT BACK TO THE HOSPITAL WITH A RIGHT LOWER EXTREMITY WEAKNESS AND HEAVINESS AND RIGHT UPPER EXTREMITY NUMBNESS. THE STROKE WAS CONFIRMED BY MAGNETIC RESONANCE IMAGING (MRI) WHICH SHOWED 1.7 CM DEEP WHITE MATTER TO POSTERIOR LEFT FRONTAL LOBE. MEDICAL INTERVENTION IS UNKNOWN, BUT THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DID NOT MENTION WHAT THEY THOUGHT CAUSED THE STROKE. ADDITIONAL INFORMATION WAS RECEIVED. CHADSVASC 2. RHYTHM WAS SINUS BEFORE AND DURING ABLATION. THE PATIENT¿S SYMPTOMS APPEARED AT LEAST SEVERAL HOURS AFTER THE PROCEDURE. 15MLS OF IRRIGATION WERE USED DURING ABLATION DUE TO PHYSICIAN PREFERENCE. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE STROKE RECOVERY UNIT. THE PATIENT HAD SOME PAST SUSPICIOUS PERSISTENT ATRIAL FIBRILLATION (PSAF) DIAGNOSIS BUT APPEARED TO BE PAROXYSMAL ATRIAL FIBRILLATION (PAF) AT THE TIME OF ABLATION AND PRE-ABLATION EXAMINATIONS. OCTARAY DWELLED IN THE HEART FOR 30 MINUTES WHILE ACT WAS ~320 S, AS PHYSICIAN BLOUSED MORE HEPARIN TO GET PATIENT TO 350 ACT. PRE-ABLATION CT SHOWED NO THROMBUS. 60UNITS OF PROTAMINE WERE GIVEN AFTER ABLATION. EJECTION FRACTION LOOKED GOOD BY ICE PRE ABLATION AND WAS 60% VIA ECHO AFTER THE STROKE. THE PATIENT HAD A HISTORY OF CARDIOMYOPATHY YEARS AGO AND THEN AGAIN, AND THIS YEAR PRIOR TO ABLATION. THE PATIENT HAD A HIGH BMI, ABOUT 300+ LBS, AND WAS ON UNINTERRUPTED ELIQUIS FOR ANTICOAGULATION. STROKE. RIGHT LOWER EXTREMITY WEAKNESS & HEAVINESS AND RIGHT UPPER EXTREMITY NUMBNESS DAY AFTER PROCEDURE. 3 CATHETER EXCHANGE (OCT -> VP -> OCT), 25 ABLATIONS (24 COMPLETE; 1 INCOMPLETE), LSPV 1 2 3 6 (INC) 7 (5 ABL; 1 INCOMPLETE), LIPV 4 5 8 9 (4 ABL), RI 10 11 12 13 22 (5 ABL), R CARINA 14 15 21 (3 ABL), AND RS 16 17 18 19 20 23 24 25 (8 ABL). TIMELINE MAPPING: 10:28 ¿ 10:35, ABL: 10:53 ¿ 11:25, MAPPING: 11:36 ¿ 11:48, AND VP INTERNAL LOT (EEPROM). WORKFLOW INVOLVED A NORMAL RANGE OF ABLATIONS (24 COMPLETE). WORKFLOW NORMAL, NO MAJOR CONCERNS WITH ABLATION LOCATIONS OR TIMING. CLEAN PULMONARY VEIN ISOLATION (PVI) ONLY WITH GOOD CATHETER MOVEMENT. NORMAL NUMBER OF CATHETER EXCHANGES WITH OCTARAY TO MAP AND VP TO ABLATE. BASELINE IMPEDANCE WAS WITHIN NORMAL RANGE, A FEW OHMS BELOW THE CLINICAL AVERAGE. CURRENT CORRESPONDED WELL. NO CLEAR CARTO/GENERATOR LEVEL CONTRIBUTORS TO STUDY ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142213 | VARIPULSETM CATHETER | PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION | QZI | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Hospitalization| L | CARTO 3 SYSTEM.| TRUPULSE GENERATOR, US.| UNK_OCTARAY NAV. |