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

Catalog Number	NR7TCSIY
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and the irrigation issue on the device occurred during use on the patient.Initially it was reported that the irrigation holes seem to be blocked.No patient consequence was reported.Additional information was received on 11-jan-2024.The issue was noted during the device being used on the patient.It was unknown if there was an error noted from the irrigation pump.It was unknown if the pump was switching from ¿low¿ to ¿high¿ flow during the ablation.Correct catheter settings were selected on the generator.Replacing the catheter resolved the issue.This event was originally considered non-reportable, however, bwi became aware that the irrigation issue on the device occurred during use on the patient on (b)(6) 2024 and have reassessed the event as reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation (b)(6) 2024.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 a patient underwent an ablation procedure with a navistar® rmt thermocool® electrophysiology catheter.It was reported that the irrigation holes seem to be blocked.No patient consequence was reported.Additional information was received.The issue was noted during the device being used on the patient.Replacing the catheter resolved the issue.The device evaluation was completed on (b)(6) 2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation, irrigation, and patency test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed no blockage in irrigation holes; however, a bent mark close to the tip section.An irrigation and patency test was performed; however, an occlusion was detected.Further investigation revealed that the irrigation tube in the bent mark was found also bent.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The bent condition observed in the tip and irrigation tube could be related to the irrigation issue reported by the customer; therefore, the customer complaint was confirmed.The root cause of the bent condition could be related to the handling of the device during the procedure; however, this can not be conclusively determined.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿irrigation holes seem to be blocked¿.In addition, the biosense webster inc.Analysis finding of the ¿bent mark close to the tip section".Investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the customer¿s reported ¿irrigation holes seem to be blocked¿.In addition, the biosense webster inc.Analysis finding of the ¿irrigation tube was bent¿.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18627501
• Report Number: 2029046-2024-00372
• Device Sequence Number: 7791073
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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: 02/23/2026
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 31002145M
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 02/15/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/13/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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: UNK GENERATOR.; UNK_SMARTABLATE PUMP.
• Patient Sex: Unknown