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

Catalog Number	BN7TCDF4L
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrioventricular (av) node ablation procedure with an ez steer nav and the patient experienced pacemaker lead dislodgement that required re-implantation of the pacemaker lead.It was reported that after successfully implanting the pacemaker device in the patient, and after the av node ablation was completed, when the physician was removing the ez steer nav from the body, the ez steer nav became "caught" on one of the pacemakers leads in the patient, and the lead was dislodged.There was no capture or morphology for the pacemaker lead.The medical intervention provided was to re-implant or re-add the pacemaker lead into the patient.The patient was reported to be in stable condition.Patient did not require extended hospitalization; they were slotted to stay overnight either way.There was no physical damage to the device.
Additional Manufacturer Narrative
On 2-jun-2025, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Note: for field h6.Health effect - clinical code ¿appropriate term / code not available (e2402) was used to represent the pacemaker lead dislodgement from the tissue.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that after successfully implanting the pacemaker device in the patient, and after the av node ablation was completed, when the physician was removing the ez steer nav from the body, the ez steer nav became "caught" on one of the pacemaker leads in the patient, and the lead was dislodged.There was no capture or morphology for the pacemaker lead.The medical intervention provided was to re-implant or re-add the pacemaker lead into the patient.The patient was reported to be in stable condition.Patient did not require extended hospitalization, they were slotted to stay overnight either way.There was no physical damage to the device.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and revision of all features were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.Due to the entrapment issue reported by the customer, a dimensional test was performed, and the device passed within specifications a manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The root cause of the adverse event remains unknown.The instruction for use (ifu) contains the following warning and precautions: careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Use both fluoroscopy and electrograms to monitor the advancement of the catheter to the desired area to avoid vascular or cardiac damage.Do not use excessive force to advance or withdraw the catheter.As part of johnson & johnson medtech'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 ref.# (b)(4).

• 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: 22132591
• Report Number: 2029046-2025-01779
• Device Sequence Number: 8408424
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)280310(10)31582865M
• 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,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31582865M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; CARTO3 EXTERNAL REFPATCH 6PACK.; NGEN RF GENERATOR, US.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Race: White