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

Model Number	NS7TCDL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a ventricular tachycardia ablation procedure with a navistar¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Cardiac tamponade occurred during ablation of right ventricular apex.The patient¿s blood pressure decreased.Timing when complaints occurred was during operation of the ablation catheter.Ablation was discontinued and pericardial drainage was performed.As blood pressure and respiration were stable, the patient was immediately transferred to the operation room.Atrial septal puncture was not performed.Ablation was performed.Steam pop was not confirmed.Non-irrigation catheter was used.The physician's opinions on the relationship between the event and the product was that the right ventricular apex was ruptured from the endocardial side during catheter manipulation using the ablation catheter.Not a product-related complication.There were no abnormalities observed prior to and during use of the product.Relevant medical history was vt ablation performed two weeks before this ablation.The patient had no other surgical history.Additional information was received.It was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was procedure related.The right ventricular apex was ruptured from the endocardial side during catheter manipulation using the ablation catheter.Not a product-related complication.Pericardial drainage was provided.When the cardiac tamponade occurred, blood pressure was decreased from 100 to 50mmhg.After the treatment, blood pressure was recovered to 80mmhg.There were no problems with respiration or tachycardia.The event occurred during the ablation phase.No error message observed.The non-contact force catheter was used.After the cardiac tamponade, thoracotomy was performed to stop the bleeding and the hemostasis was achieved.The patient was followed up in the hospital and recovered.Patient did not require extended hospitalization because of the adverse event.Transseptal puncture was not performed.Prior to noting the cardiac tamponade, ablation was performed.No evidence of a steam pop.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30932549m and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

• 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: 16619879
• Report Number: 2029046-2023-00649
• Device Sequence Number: 15233457
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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 Expiration Date: 10/19/2025
• Device Model Number: NS7TCDL174HS
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30932549M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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: SMARTABLATE GEN. KIT (JAPAN)
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 44 KG