MAUDE Adverse Event Report: BIOSENSE WEBSTER INC VARIPULSE¿ BI-DIRECTIONAL CATHETER; PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION

Catalog Number	D141201
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During cardiac ablation procedure with a varipulse/qdot catheter, the patient experienced stroke/cerebral infarct.The report indicated during a cti (cavo tricuspid isthmus) line was done with qdot micro catheter, followed by atrial fibrillation ablation with the varipulse catheter.Before any ablation with the varipulse occurred, an error occurred on the pump when the varipulse was in the left atrium.The physiologist accidentally flushed the catheter before the flow was closed to the patient for approximately 1 second.The doctor then took the catheter out and the medical team flushed outside of the body.Everything else about the procedure was normal.Act (activated clotting time) was above 350 before ablation as stated in varipulse ifu (instructions for use).28 lesions were done including posterior wall.The product was not used in a clinical trial.The stroke/cerebral infarct event was discovered when the patient was waking up from general anesthesia.The surgery was not prolonged due to the event.Two reports have been submitted for this event, one for the varipulse and one for the qdot.This report is for the varipulse.
Additional Manufacturer Narrative
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.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 (trans ischemic accident).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.An 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.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).
Additional Manufacturer Narrative
On 7-apr-2026, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.During cardiac ablation procedure with a varipulse/qdot catheter, the patient experienced stroke/cerebral infarct.The report indicated during a cti (cavo tricuspid isthmus) line was done with qdot micro catheter, followed by atrial fibrillation ablation with the varipulse catheter.Before any ablation with the varipulse occurred, an error occurred on the pump when the varipulse was in the left atrium.The physiologist accidentally flushed the catheter before the flow was closed to the patient for approximately 1 second.The doctor then took the catheter out and the medical team flushed outside of the body.Everything else about the procedure was normal.Act (activated clotting time) was above 350 before ablation as stated in varipulse ifu (instructions for use).28 lesions were done including posterior wall.The product was not used in a clinical trial.The stroke/cerebral infarct event was discovered when the patient was waking up from general anesthesia.The surgery was not prolonged due to the event.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and revision of all device features were performed.Visual inspection revealed no damage or anomalies on the device.The device was connected to carto 3 system and trupulse generator and it was recognized and visualized correctly, no magnetic or noise issues were found.Device was deflected and irrigated during the test and no issues were found.A pulse field ablation (pfa) test was performed and the device was working correctly, no issues were observed in the generator.A manufacturing record evaluation was performed for the finished device number 31736194l, and no internal actions related to the reported complaint were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The instructions for use (ifu) states the following recommendations: when using the catheter with conventional systems (such as fluoroscopy or intracardiac echocardiography), with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement should be done under direct imaging guidance.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released 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).

• Brand Name: VARIPULSE¿ BI-DIRECTIONAL CATHETER
• Common Device Name: PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24737995
• Report Number: 2029046-2026-01031
• Device Sequence Number: 8859716
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• UDI-Public: (01)10846835025460(17)260902(10)31736194L
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D141201
• Device Lot Number: 31736194L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3013300026-01/17/2025-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown