MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; 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	08/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.There is no information for this lot ad25130053 therefore mre can¿t be performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.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).
Event or Problem Description
During an isvt (supraventricular tachycardia) ablation with a qdot catheter and decanav catheter, the patient experienced pericardial effusion treated with pericardiocentesis.The patient was stale after treatment.During the procedure, the medical team mapped the rv (right ventricle) and got an area of interest "sort of septal rv close to the his".They "poked around a lot" with the decanav catheter into the rv apex and physician decided it was "good enough" to burn.They had a great signal but were unable to capture when pacing in a lot of areas in the rv and the physician kept poking around until they found a spot that would intermittingly capture.Before burning they placed the decanav catheter in the rv to have for backup pacing.They were not able to capture the rv due to the patient having a "super small right ventricle".The physician suspects they may have "poked a little too much" and caused a pericardial effusion.They burned the pvc (premature ventricular contraction) and the physician realized there was a pericardial effusion -- the physician had burned and did a couple of lesions they were looking at it on ice (intracardiac echocardiography) and noticed the pericardial effusion.Pericardiocentesis was performed on the patient.The patient left the room stable and is currently in recovery.Bwi products in use during the case were qdot micro catheter, decanav catheter, soundstar catheter, vizigo sheath, carto 3 system, and ngen generator.The physician¿s opinion on the cause of this adverse event was patient condition/procedure.Prior to noting the pe/ct (pericardial effusion / cardiac tamponade), ablation was performed.The event occurred after the ablation phase.The outcome of the adverse event was that the patient left the room stable.The physician was confident the patient would recover fully.The patient did not require extended hospitalization.No catheter exchanges occurred during the procedure or transseptal puncture performed during the procedure.No evidence of steam pop.The flow settings for irrigation catheter were qmode, high flow max: 15 ml/min, and high flow min: 4ml/min.The patient did not require cardiac surgery.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.No error messages observed on biosense webster equipment during the procedure.The force visualization features used were dashboard, vector and visitag.The visitag module parameters for stability used were min.Time 3 sec, tag size 3, and fot 25%.No additional filter was used with the visitag.The color option prospectively used was impedance.The adverse event occurred on 26-aug-2025.Ngen was used for the procedure.There were two reports for this event, one for the qdot and another for the decanav.This report is for the decanav.
Additional Manufacturer Narrative
On 20-oct-2025, the device manufacture and expiration dates were received.They have both been added to respective fields.Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and revision of all features were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 26-sep-2025, the bwi product analysis lab 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23088788
• Report Number: 2029046-2025-03206
• Device Sequence Number: 10508905
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 04/12/2026
• Device Catalogue Number: R7F282CT
• Device Lot Number: AD25130053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 10/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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 MDC.; CARTO 3.; NGEN GENERATOR.; NGEN PUMP.; SOUNDSTAR ECO GE 8F CATHETER.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American