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

Catalog Number	BD7TCFJ8L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter procedure with a ez steer¿ ds bi-directional electrophysiology catheter and the medical team noted excessive kinking of the catheter at the distal tip.This was identified on fluoroscopy after the catheter had entered the right atrium.This created difficulty in getting good catheter contact with tissue and stability.Catheter was ok to deliver radiofrequency (rf) energy and no issues with impedance temperature noted during ablation, but the kink made physical maneuvering of the catheter difficult.Physician was able to complete the procedure by taking a steerable vizigo sheath to add stability to the kinked catheter, but this would not his preferred course of action or a usual practice in his workflow.There was a 2-3 minute delay while procuring the steerable sheath.The procedure was completed without further incident.The catheter kink was identified upon removal of the device.No patient consequences were reported.
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).
Additional Manufacturer Narrative
On 6-feb-2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial flutter procedure with a ez steer¿ ds bi-directional electrophysiology catheter and the medical team noted excessive kinking of the catheter at the distal tip.This was identified on fluoroscopy after the catheter had entered the right atrium.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection was performed following j&j procedures.Visual analysis in the lab revealed that the tip was observed kinked and wrinkled, no wires or internal components were exposed.The damage observed could be related to the manipulation of the device during the procedure, however, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 31508529m and no internal actions related to the complaint were found during the review.The damage identified on the tip during the analysis could be related knotted issue reported by the customer; therefore the complaint was confirmed.The potential cause of the issue cannot be established.The instructions for use contain (ifu) the following warning and precaution: always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the catheter.Do not manually pre-shape the distal shaft of the catheter by applying external forces intended to bend or affect the intended shape or curve of the catheter.O not scrub or twist the distal tip electrode during cleaning.Do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.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'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: EZ STEER¿ DS 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: 21297828
• Report Number: 2029046-2025-00343
• Device Sequence Number: 7775833
• Product Code: LPB
• UDI-Device Identifier: 10846835002607
• UDI-Public: (01)10846835002607(17)271118(10)31508529M
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: BD7TCFJ8L
• Device Lot Number: 31508529M
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIZIGO SHEATH, 8.5F INNER DIAMETER.
• Patient Sex: Unknown