MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCFJ8L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a ez steer nav ds and the catheter tip was broken.There was no adverse patient consequence.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j) for evaluation.As such, section d9 has been populated.It was reported that a patient underwent a cardiac ablation procedure with a ez steer nav ds and the catheter tip was broken.There was no adverse patient consequence.Device investigation details: a visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed a bent mark in the tip section; however, no internal components were observed exposed.No other damage or anomalies on the device were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The broken tip reported by the customer could not be confirmed during the analysis.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The bent mark was not related to the reported event, and the potential cause could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.As part of the johnson & johnson medtech 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: EZ STEER NAV DS
• 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: 24398559
• Report Number: 2029046-2026-00575
• Device Sequence Number: 8299595
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: (01)10846835003048(17)281103(10)31785342M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010068/S6
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: BN7TCFJ8L
• Device Lot Number: 31785342M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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