MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCDL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation with a navistar¿ electrophysiology catheter and the patient experienced cardiac tamponade that required medical intervention and hospitalization.A pericardial tamponade was confirmed in right ventricle with bsx woven catheter.Biosense navistar¿ electrophysiology catheter was in right atrium but was not used for navigation when the tamponade occurred.The physician successfully performed an avnrt with the biosense webster 4mm navistar catheter.During the waiting time after the ablation, the physician realized that there is a tamponade in the right ventricle.The physician reported that he probably perforated already when he placed the rv in the right ventricle before the 4mm nav catheter was in the heart and the ablation started.The physician treated the tamponade on his own by giving "butamin".This stopped the bleeding after several minutes.No thoracal puncture was necessary.The patient was kept on table until blood pressure was stabilized.The patient was transferred to the intensive care unit for supervision for one night.The physician mentioned already during the procedure that he might have punctured the wall of the right ventricle with a bsx woven rv catheter.However, the physician still continued the procedure as no consequences appeared.Change in blood pressure only arose when he took out the rv catheter.No irrigated catheter was used.No error messages were displayed.The physician's opinion on the cause of this adverse event was patient condition (tiny older patient).Patient has improved.Patient required extended hospitalization.No evidence of steam pop.Although physician believes he had perforated the rv (right ventricle), it has not been confirmed and ablation had occurred prior to noting the cardiac tamponade.Therefore, the navistar¿ electrophysiology catheter cannot be disassociated from the adverse event.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation with a navistar¿ electrophysiology catheter and the patient experienced cardiac tamponade that required medical intervention and hospitalization.A pericardial tamponade was confirmed in right ventricle with bsx woven catheter.Biosense navistar¿ electrophysiology catheter was in right atrium but was not used for navigation when the tamponade occurred.The physician successfully performed an avnrt with the biosense webster 4mm navistar catheter.During the waiting time after the ablation, the physician realized that there is a tamponade in the right ventricle.The physician reported that he probably perforated already when he placed the rv in the right ventricle before the 4mm nav catheter was in the heart and the ablation started.The physician treated the tamponade on his own by giving "butamin".This stopped the bleeding after several minutes.No thoracal puncture was necessary.The patient was kept on table until blood pressure was stabilized.The patient was transferred to the intensive care unit for supervision for one night.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi 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 31176278m number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The physician's opinion on the cause of this adverse event was patient condition.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 biosense webster¿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 reference number: (b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, 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: 18603354
• Report Number: 2029046-2024-00328
• Device Sequence Number: 21106758
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: NS7TCDL174HS
• Device Lot Number: 31176278M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: BOSTON SCIENTIFIC WOVEN CATHETER; SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female