MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECAN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7D282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/01/2025
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.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
It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav catheter and the patient experienced pericardial effusion treated with pericardiocentesis and prolonged hospitalization.The patient had just been cardioverted when the physician was checking for the catheter location using intracardiac echocardiography (ice) when the pericardial effusion was discovered and confirmed.Pericardiocentesis was performed and the patient was sent to the intensive care unit (icu).The physician believed they may have perforated when attempting to insert the decanav catheter into the corinary sinus (cs) due to a difficult anatomy.They reported that after they had difficulty inserting the decanav catheter, and they decided to remove the catheter and then went transeptal with no issues.They cardioverted the patient before they attempted to reinsert the decanac again into the cs.They were able to get into the cs the 2nd time with no issues.The physician thought the perforation occurred during the 1st attempt to insert the decanav into the cs, but they could not confirm.This was a pfa case using a farawave catheter with the farapulse system.The decanav catheter and the octaray catheter were used for mapping.Additional infomration was later received indicating the patient required cardiac surgery because of perforation through free wall of right ventricle and oblique sinus.The physician¿s opinion on the cause of this adverse event was that he perforated somewhere in the right atrium while trying to properly place the decanav catheter in the cs.The intervention provided was that the patient was tapped and sent to the operating room (or) for further examination.The patient¿s outcome from the adverse event was reported as fully recovered.2400ml pulled.Other relevant history/preexisting conditions included of hypertension, heart failure, type 2 diabetes, pure hypercholesterolemia, and vitamin d deficiency.The procedural activated clotting time (act) before procedure was 273, and the procedural act during procedure was 320.The sheath and the catheters exchanged were 1 sheath and 2 catheters.One transseptal puncture site was performed during the procedure with baylis.Pulsed field ablation (pfa) was intended, but no applications/ablation were made/performed.No evidence of steam pop.The event occurred during the mapping phase.The flow setting for irrigated catheter used was octaray was set.

• Brand Name: DECAN
• 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: 23375385
• Report Number: 2029046-2025-03543
• Device Sequence Number: 18360313
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: (01)10846835008791
• 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: R7D282CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/23/2025
• 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: BAYLIS NEEDLE.; CARTO 3 SYSTEM.; FARAPULSE SYSTEM.; FARAWAVE CATHETER.; NGEN MONITOR STAND.; OCTARAY CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic
• Patient Race: White