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

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation was completed on 01-apr-2025.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 11-feb-2025.Following j&j medtech procedures a visual inspection of the returned device were performed.Visual inspection revealed internal components exposed on the tip area.Due to this condition, a manufacturing (mfg) meeting was necessary.After review the returned catheter and according to records, the investigation was completed.The catheter passed all quality criteria defined in process flow.However, this could not be conclusively determined.The assignable cause of the problem remains undetermined.Additional information received revealed that the customer observed that wires were not exposed, neither lifted nor sharp rings.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The exposed components could be related to the issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause for the internal components exposed could be related to the handling of the device after the procedure; however, this cannot be conclusively determined.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with ez steer nav for which biosense webster¿s product analysis lab (pal) identified internal components exposed on the tip area.It was reported that the tip of the catheter was bent once the catheter was removed from the body.When the catheter was replaced, the procedure continued.No patient consequence reported.Additional information was received.No wires were exposed.The damage did not result in lifted or sharp rings.Does not believe there was resistance in inserting or removing the catheter.Believes the issue was about an inch away from the distal tip.Does not have a picture.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 01-apr-2025 observed internal components exposed on the tip area.The event was originally considered non-reportable, however, bwi became aware of internal components exposed on the tip area on 01-apr-2025 and have assessed this returned condition as reportable.

• Brand Name: EZ STEER NAV
• 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: 21903316
• Report Number: 2029046-2025-01315
• Device Sequence Number: 21014958
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)271118(10)31503351M
• 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): 04/24/2025

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: BN7TCDF4L
• Device Lot Number: 31503351M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/24/2025
• 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: UNK_NGEN RF GENERATOR
• Patient Sex: Unknown