MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCDH
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A video was received for evaluation following johnson & johnson medtech's procedures.According to video provided by the customer, the catheter was flushed with a syringe; however, no flow was observed through the irrigation hole.A manufacturing record evaluation was performed for the finished device number lot 31649949m and no internal action related to the complaint was found during the review.The bwi product analysis lab received the device for evaluation.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.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 atrioventricular reentrant tachycardia / wolff-parkinson-white (wpw) syndrome ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the device (including port, luer hub) was not irrigating.A second device was used to complete the operation.There was no adverse event reported on patient.
Additional Manufacturer Narrative
On 10-sep-2025, the product investigation was completed.It was reported that a patient underwent an atrioventricular reentrant tachycardia / wolff-parkinson-white (wpw) syndrome ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the device (including port, luer hub) was not irrigating.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and irrigation test of the returned device were performed following j&j medtech procedures.Visual analysis revealed reddish material in the luer hub.An irrigation test was performed, and the catheter failed the test due to the irrigation tube was found bent at the shaft area.A manufacturing record evaluation was performed for the finished device number lot 31649949m and no internal action related to the complaint was found during the review.The irrigation issue reported by the customer was confirmed.The potential cause of the irrigation tube bent could not be conclusively determined.The reddish material observed in the luer hub is related to the procedure.The instructions for use contain the following recommendations: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j medtech's quality system.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: NAVI-STAR¿ THERMO-COOL¿ 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22982859
• Report Number: 2029046-2025-03026
• Device Sequence Number: 9549820
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: (01)10846835000559(17)280520(10)31649949M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/01/2025

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 Catalogue Number: NI75TCDH
• Device Lot Number: 31649949M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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
• Patient Sex: Unknown