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

Model Number	NR7TCSIY
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a deflection stuck issue occurred.The navistar® rmt thermocool® electrophysiology catheter tip was very flimsy and was not responding correctly about mid-case.The physician had to remove the navistar® rmt thermocool® electrophysiology catheter and they had to disengage the magnetic to remove the navistar® rmt thermocool® electrophysiology catheter as it was acting like it was stuck.The navistar® rmt thermocool® electrophysiology catheter was exchanged and the issue was resolved.There was no patient consequence reported.Additional information was received.Magnets were not engaged.There was difficulty in removing the catheter.There was no ring, electrode or other physical damage observed at the distal end of the catheter.The event was assessed as mdr reportable for a deflection stuck issue.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 08-dec-2022.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.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
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a deflection stuck issue occurred.The navistar® rmt thermocool® electrophysiology catheter tip was very flimsy and was not responding correctly about mid-case.The physician had to remove the navistar® rmt thermocool® electrophysiology catheter and they had to disengage the magnetic to remove the navistar® rmt thermocool® electrophysiology catheter as it was acting like it was stuck.The navistar® rmt thermocool® electrophysiology catheter was exchanged and the issue was resolved.There was no patient consequence reported.Additional information was received.Magnets were not engaged.There was difficulty in removing the catheter.There was no ring, electrode or other physical damage observed at the distal end of the catheter.The device evaluation was completed on 17-jan-2023.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual analysis of the returned sample revealed no damages on the navistar rmt thermocool device.A deflection test cannot be performed.However, a closer inspection was performed in order to verify if there is an anomaly in the device.Coil and magnets were found in good conditions, wires and irrigation tube in a correct position.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of bwi's quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any assembly issues.The event described could not be confirmed as the device performed without any assembly issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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® ELECTROPHYSIOLOGY CATHETER
• 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16006954
• Report Number: 2029046-2022-03171
• Device Sequence Number: 6678820
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2025
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30876393M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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: UNKNOWN BRAND CATHETER
• Patient Sex: Unknown