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	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tamponade was observed at the end of the case, after the catheter was pulled out from the patient.Action taken when the event occurred was "drain".Additional information was received indicating the event used during use of the bwi products during mapping and ablation phase but observed the tamponade only at the end of the case.The physician¿s opinion on the cause of the adverse event were bwi product malfunction and patient condition.There was no evidence of steam pop.No surgery was required.Patient was reported to have fully recovered.On 6-feb-2025, additional information was received indicating there were no bwi product malfunctions and ablation was not done prior to the adverse event.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
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 that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a decanav and the patient experienced cardiac tamponade that required "drain".Tamponade was observed at the end of the case, after the catheter was pulled out from the patient.Action taken when the event occurred was "drain".Additional information was received indicating the event used during use of the bwi products during mapping and ablation phase but observed the tamponade only at the end of the case.The physician¿s opinion on the cause of the adverse event were bwi product malfunction and patient condition.There was no evidence of steam pop.No surgery was required.Patient was reported to have fully recovered.
Additional Manufacturer Narrative
On 27-jan-20245, 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
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21127888
• Report Number: 2029046-2025-00112
• Device Sequence Number: 7677486
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)251017(10)31475723M
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,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: 10/17/2025
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31475723M
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 01/30/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/28/2025; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: 7FR DECAN,11P, F, 2.4MMLE, 282MM.; NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male