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	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia procedure (idvt) procedure with a decanav catheter and a thermocool smarttouch sf catheter and the patient suffered a pericardial effusion treated with a pericardiocentesis.During a procedure, while mapping in the right ventricle with the decanav catheter, the physician noticed a small effusion.After a few ablations, the effusion was getting bigger per intracardiac echocardiography (ice) catheter imaging and the physician abandoned the ablation.The pericardial effusion was confirmed with ice.The medical intervention provided was a pericardiocentesis and 100 cc of fluid was removed.The patient is in a stable condition.The physician did not know how the effusion occurred.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.This adverse event was assessed as mdr reportable under both the decanav catheter and a thermocool smarttouch sf catheter.(b)(6).
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 31573711m and no internal actions related to the complaint was found during the review.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.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: 22101939
• Report Number: 2029046-2025-01733
• Device Sequence Number: 12581911
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)260211(10)31573711M
• 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
• Report Date (Section B): 05/28/2025

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: 02/11/2026
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31573711M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.5F SHEATH WITH CURVE VIZ LGC; CARTO 3 SYSTEM; NGEN RF GENERATOR, US; STERILMED SOUNDSTAR CATHETER R10439011; THMCL SMTCH SF BID, TC, D-F
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown