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 Perforation (2513)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction ablation procedure with a decanav catheter and the patient experienced cardiac perforation which required pericardiocentesis.During the mapping phase, a pericardial effusion occurred.The injury occurred when the decanav catheter was going up to map and perforated the left atrial appendage.The injury was confirmed by intracardiac echocardiogram.No ablation was performed.They performed a pericardial tap and removed 1.5 liters of fluid from the patient.The patient was stable and required extended hospitalization to monitor for recurrent effusion.Patient has improved.The physician¿s opinion on the cause of this adverse event is that they believe it was caused by the decanav perforating the left atrial appendage.
Additional Manufacturer Narrative
On (b)(6) 2026, the (b)(6) received the complaint device for evaluation.The product 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 ref.# (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: 50756271
• Report Number: 3013300026-2026-03006
• Device Sequence Number: 9333357
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• 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
• Type of Report: Initial

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: AD26200003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2026
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male