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	Heart Block (4444); Pericarditis (4448)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31062823m and no internal action related to the complaint was found during the review.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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent avnrt (atrioventricular nodal reentrant tachycardia) ablation that included navistar catheter.The patient experienced third degree av block that required prolonged hospitalization.Timing: during ablation.Description of health hazard: heart block.It was reported by the caller, a clinical account specialist, that a third-degree heat block was discovered during ablation.The caller stated that the patient was woken up from anesthesia and appropriate drugs were given.The patient is now in observation, there is some firing right now, but will be staying overnight for observation.If not better a pacemaker will be put in tomorrow.The patient is in stable condition at this time.Physician's opinion on the cause of this adverse event: procedure, patient condition.Intervention provided: permanent pacemaker implant.Outcome of event: worsened, during pmi patient had a lead perforation eventually requiring a centesis.Lead fell out of position and required repositioning.Patient potentially has pericarditis.Subsequent afib noted on monitor.Generator information: smartablate, m490002, g4c-0562.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

• 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: 17494922
• Report Number: 2029046-2023-01733
• Device Sequence Number: 7826788
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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 Expiration Date: 05/22/2026
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31062823M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown