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	Pericardial Effusion (3271)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The report indicated that after cardiac ablation procedure which included the use of a decanav catheter, the patient experienced decreased blood pressure, pericardial effusion (no drainage performed but medication was provided).After the procedure, the patient's blood pressure decreased, and cardiac tamponade was suspected.Pericardial effusion accumulation (no drainage performed), and the issue was not resolved.No extended hospitalization was required.The physician's opinion on the relationship between the event and the product was that there was a possibility that excessive pressure was applied during the left ventricular (lv) map with decanav catheter.There were no abnormalities observed prior to or during use of the products.Additional information received indicated that no drainage was performed.Medication administered were norepinephrine and fluid supply.The patient recovered.During the procedure, one catheter exchange was used for each area, and one transseptal puncture site was performed during the procedure.The procedural activated clotting time (act) was 350-400 seconds.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31441818m and no internal action related to the complaint was found during the review.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).

• 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: 21974568
• Report Number: 2029046-2025-01457
• Device Sequence Number: 9274504
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)250911(10)31441818M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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 Expiration Date: 09/11/2025
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31441818M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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: NGEN PUMP, JAPAN CONFIGURATION; NGEN REMOTE MONITOR, JAPAN; QDOT MICRO, BI, TC, D-F; SOUNDSTAR ECO SMS 8F CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian