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	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: 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.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field 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 ref.# (b)(4).
Event or Problem Description
After cardiac ablation and mapping with a decanav catheter, the patient experienced blood pressure drop and pericardial perforation treated with pericardiocentesis and 1.2liters of blood was tapped from the pericardial space and patient required prolonged hospitalization.The report indicated that the patient experienced a pericardial effusion.After pulling the catheters on a non-inducible supraventricular tachycardia (svt), the patient's blood pressure began to drop.The electrophysiologist used a thoracic ultrasound to discover and confirm the pericardial effusion.The medical intervention provided was a pericardiocentesis and 1.2 liters of blood was tapped from the pericardial space.The last known patient status was stable.Additional information received indicated that the physician¿s opinion on the cause of this adverse event was the result of the procedure, and not a malfunction of bwi products.The outcome of the adverse event was that as of (b)(6) 2025, the patient¿s condition improved.The patient required extended hospitalization because of monitoring the patient following pericardiocentesis.No catheter exchanges occurred during the procedure, and no transseptal puncture site was performed during the procedure.No ablation was performed, as such, no evidence of steam pop.No irrigated catheter was used.The patient did not require cardiac surgery.It can be reasonably assumed that this was caused by a cardiac perforation, but i do not believe that it was directly confirmed with surgical intervention.

• 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): 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: 24079207
• Report Number: 2029046-2026-00183
• Device Sequence Number: 18615895
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR DEFL,4P,D,SD,252,12PR; CARTO 3 SYSTEM; FIX 6F,4P,A,SD,5MM,12PN; NGEN GENERATO
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Female