MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCDF8L
Medical Device Problem Codes	Material Separation (1562); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter - right ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and the physician stated that the catheter was no longer deflecting and was not getting great contact.The device was "visually broken", which the physician confirmed to mean that the catheter was bent at the tip.The damage was done at the very distal portion of the catheter.There were no exposed wires, lifted rings, or sharpened rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was no pre-shaped.The catheter was replaced and the procedure was continued.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed that the tip of the device was found bent with no wires exposed.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device 31069942m number, and no internal actions related to the reported complaint condition were identified.Since a bent mark was observed in the tip area, this failure could be related to the broken condition reported by the customer; therefore, the customer complaint was confirmed.The damage observed in the tip could be related to the excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.It should be noted that product failure is multifactorial.The deflection issue reported by the customer could not be replicated during the product investigation.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).

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17791155
• Report Number: 2029046-2023-02142
• Device Sequence Number: 14981007
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: 10846835003000
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2023

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 Expiration Date: 06/20/2026
• Device Catalogue Number: BN7TCDF8L
• Device Lot Number: 31069942M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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