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	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Note: for field d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Manufacturer's ref.# (b)(4).
Event or Problem Description
During idiopathic ventricular tachycardia (idvt) ablation procedure with a decanav catheter and the patient experienced pericardial effusion treated with pericardiocentesis.It was reported that during the case, a pericardial effusion was noticed in the patient.When initially advancing the decanav catheter into the body for mapping, the decanav catheter had advanced into the epicardial space.The pericardial effusion was discovered and confirmed on intracardiac echocardiography (ice).The medical intervention provided was pericardiocentesis, and about 500ml of fluid was removed.The patient is in stable condition.The physician believes the cause of the pericardial effusion was due to the decanav catheter being advanced into epicardial space.Additional information was received indicating the physician¿s opinion on the cause of this adverse event was fellow in training caused; not product or catheter related per md.The patient did not require extended hospitalization.The outcome of the adverse event was fully recovered (no residual effects).It was also reported that after continuing the procedure, the carto 3 system displayed error 105- map: catheter sensor error.The cable was replaced without resolution.The thermocool smarttouch sf catheter was replaced, and the issue was resolved.The procedure continued.The customer¿s reported catheter sensor issue itself is not considered to be mdr reportable event since the since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.
Additional Manufacturer Narrative
On 11-nov-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).
Additional Manufacturer Narrative
During idiopathic ventricular tachycardia (idvt) ablation procedure with a decanav catheter and the patient experienced pericardial effusion treated with pericardiocentesis.Device evaluation details: the product was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and revision of all features were performed following johnson & johnson medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed.No magnetic, deflection, or electrical issues were found during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.The physician's opinion on the cause of the adverse event was not product or catheter related per the physician.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 the johnson & johnson medtech 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.# pc-(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): 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: 23486832
• Report Number: 2029046-2025-03734
• Device Sequence Number: 16074203
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(10)AD25280074
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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

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: 07/28/2026
• Device Catalogue Number: R7F282CT
• Device Lot Number: AD25280074
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 11/21/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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: SOUNDSTAR ECO GE 8F CATHETER.; THMCL SMTCH SF BID, TC, D-F.; THMCL SMTCH SF UNID, TC, F.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White