MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER DS; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BD7TCFJ8L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31757213m and no internal actions related to the complaint were found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 an ez steer ds and fragility was observed at the distal tip of the catheter.The distal tip could easily be detached by plicating it.There was no adverse patient consequence reported.Additional information indicated that it is clear that the catheter presented a curve at the distal tip level (probably made like this) but according to the surgeon's expertise, this curve constitutes a point of weakness of the catheter which during ablation, in particular flutter, tends to bend toward the septum.

• Brand Name: EZ STEER DS
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 24077715
• Report Number: 2029046-2026-00178
• Device Sequence Number: 15881288
• Product Code: LPB
• UDI-Device Identifier: 10846835002607
• UDI-Public: (01)10846835002607(17)280909(10)31757213M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P950005/S19
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: BD7TCFJ8L
• Device Lot Number: 31757213M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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