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

Catalog Number	BD7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Dyspnea (1816)
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinical trial, it was reported that a patient underwent a repeat atrial fibrillation ablation procedure with an ez steer¿ bi-directional electrophysiology catheter on (b)(6) 2023 and suffered dyspnea.On (b)(6) 2023, patient experienced dyspnea categorized as severe and serious, categorized by serious deterioration in the health of the subject as defined by in-patient / prolonged hospitalization (admission date: (b)(6) 2023 and discharge date (b)(6) 2023) and medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function.Relationship to study device is not related.The adverse event is expected/anticipated.The outcome is recovered/resolved.Intervention was medication and pacemaker re-programming.Device disposition was inserted and radio frequency was delivered.Additional information was provided on (b)(6) 2024.Relationship to repeat study procedure is possible.This event was originally considered non-reportable, however, bwi became aware that the relationship to the repeat study procedure is possible on (b)(6) 2024 and have reassessed the event as reportable.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(4).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history review was performed for the finished device 30936131m number, and no internal actions related to the complaint were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number:(b)(4).
Additional Manufacturer Narrative
Initially it was reported that the adverse event was expected/anticipated.Additional information received on 15-may-2024 stating it has been changed to n/a (not related/not serious).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: EZ STEER¿ 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: 18857548
• Report Number: 2029046-2024-00767
• Device Sequence Number: 19659849
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: 10846835002515
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P950005/S19
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 10/18/2025
• Device Catalogue Number: BD7TCDF4L
• Device Lot Number: 30936131M
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: NGEN RF GENERATOR.; NON-BWI SHEATH.; OCTA,LNG,48P,2-5-2-5-2,D-CURVE.; QDOT MICRO, BI, TC, D-F.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG