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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Block (4444)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
Event or Problem Description
It was reported that a patient underwent a intranodal reentry ablation procedure with a navi-star¿ rmt electrophysiology catheter and the patient suffered with complete atrioventricular block.The patient came for an intranodal reentry procedure.The catheter used was a 4mm nav.The patches were well positioned and breathing was well captured by the accuresp module.The practitioner used the ablation settings on the generator recommended for this type of catheter.However, the patient emerged from the procedure with complete atrioventricular block which was confirmed over the following days.There were no product problems reported.
Additional Manufacturer Narrative
On 23-oct-2023, additional information was received indicating the physician¿s opinion on the cause of the adverse event is that it was due to the procedure.The first sign of this adverse event was discovered during the use of biosense webster products.But it was confirm post use of biosense webster products.The patient¿s status was reported as unchanged, and the physician was thinking of a pacemaker for this patient.The smartablate system rf generator was provided as used during the procedure.As such, the product details under the concomitant product section have been updated.Additionally, the product code was provided as bn7tcdf4l, as such, the following updates have been made: d1.Brand name updated from ¿navi-star¿ rmt electrophysiology catheter¿ to ¿ez steer¿ nav bi-directional electrophysiology catheter¿ d2a.Common device name has been updated from ¿cardiac ablation percutaneous catheter¿ to ¿electrode, percutaneous, conduction tissue ablation¿ d4.Catalog has been updated from ¿unk_navistar rmt 4mm¿ to ¿bn7tcdf4l¿ d4.Unique identifier( udi) updated from ¿blank¿ to ¿(b)(4)¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: the 6.Health effect - clinical code has been corrected from arrhythmia (e0601) to heart block (e060106).

• 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: 17935951
• Report Number: 2029046-2023-02321
• Device Sequence Number: 6352556
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: SMARTABLATE GENERATOR SPARE-WW; UNKNOWN GENERATOR; UNKNOWN PATCHES
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown