MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR RMT THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NR7TCSIY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during idiopathic ventricular tachycardia - left (l-idvt) cardiac ablation procedure with a navistar rmt thermocool catheter, the patient experienced low blood pressure, pericardial effusion treated with pericardiocentesis and drainage tube placement.There was a pericardial effusion discovered during the procedure.There was "a lot of ablations" performed during the procedure.At the end of the procedure when the physician was "pulling everything out," they noticed there was a "significant" pericardial effusion present.The effusion was discovered and confirmed via intracardiac echo using a soundstar catheter.A baseline effusion was not documented.The size of the effusion discovered during the procedure was not known.The patient¿s noninvasive blood pressure was low, systolic in the 80's.A pericardiocentesis was performed and an unknown amount of fluid was removed.The drainage tube was removed prior to the patient leaving the ep lab.The patient was stable and transferred to the cardiac critical care unit for overnight observation.Additional information is not known at this time.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
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 reference number: (b)4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 04-aug-2025.The 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 reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that during idiopathic ventricular tachycardia - left (l-idvt) cardiac ablation procedure with a navistar rmt thermocool catheter, the patient experienced low blood pressure, pericardial effusion treated with pericardiocentesis and drainage tube placement.The device evaluation was completed on 28-aug-2025.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 reference number: (b)(4).

• Brand Name: NAVISTAR RMT THERMOCOOL
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22618211
• Report Number: 2029046-2025-02451
• Device Sequence Number: 13059556
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(17)280310(10)31583026M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• 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 Catalogue Number: NR7TCSIY
• Device Lot Number: 31583026M
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/28/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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: DECA CATHETER; RMT CARTO; STERILMED SOUNDSTAR; UNK_SMARTABLATE GENERATOR; UNK_VIZIGO
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown