MAUDE Adverse Event Report: Biosense Webster Inc DECANAV; Catheter, Electrode Recording, Or Probe, Electrode Recording

Catalog Number	R7F282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a decanav catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.While mapping the right ventricle during a pvc case, an abnormal path of the decanav catheter through the right ventricle into the possible pericardium was noticed.Physician was immediately notified of the catheter tracing and ultrasound images.After further assessment, the physician performed pericardiocentesis and 155 ml of fluid removed by syringe and an additional 20 ml was collected in a drainage system.The patient was stable.The patient required extended hospitalization due to drain placement.There were two to three sheath and catheter exchanges during the procedure.A total of 28 ablations were performed in the right ventricle.The correct catheter settings were selected on the generator.There were no issues with flow rate change at the start of ablation.No error messages were observed on biosense webster equipment during the procedure.The physician stated that there was no default in the product and the event was operator error, as she put the catheter in the wrong place.
Additional Manufacturer Narrative
D4: udi: the lot number provided of ad26110015 was not recognized in the system.Therefore, the full udi is currently not available.The biosense webster, inc.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.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).

• Brand Name: DECANAV
• Common Device Name: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Precision Concepts Costa Rica; saret industrial park building; rio segundo; alajuela 90109 ; CS 90109
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50217993
• Report Number: 3013300026-2026-02593
• Device Sequence Number: 10675749
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)270330(10)AD26110015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: R7F282CT
• Device Lot Number: AD26110015
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 143 LB
• Patient Race: White