MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device were performed following bwi procedures.Visual analysis revealed that the tip of the device was broken.A deflection test was performed, and the curve was deflecting within specifications.A manufacturing record evaluation was performed for the finished device 31299690m number, and no internal actions related to the reported complaint condition were identified.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The potential cause of damage on tip could be related to the handling of the device after the procedure, however, this cannot be established.The instruction for use states: do not scrub or twist the distal tip electrode during cleaning.As part of biosense webster's 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).
Event or Problem Description
It was reported that a patient underwent an svt (supraventricular tachycardia) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and post procedure the bwi product analysis lab identified a broken tip.During the procedure, the physician stated that the catheter was no longer deflecting.The catheter was replaced and the procedure was continued.No patient consequences were reported.

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20043049
• Report Number: 2029046-2024-02780
• Device Sequence Number: 20827516
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(11)240426(17)270425(10)31299690M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• 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
• Report Date (Section B): 08/22/2024

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 Catalogue Number: BN7TCDF4L
• Device Lot Number: 31299690M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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