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

Catalog Number BN7TCDF4L

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Heart Block (4444)

Event Date 08/03/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 325675220
• Report Number: 2029046-2023-02321
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR SPARE-WW; UNKNOWN GENERATOR; UNKNOWN PATCHES
• Patient Outcome(s): Other