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

Catalog Number BD7TCDF4L

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event 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.

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).

• Brand Name: EZ STEER¿ 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: 18857548
• MDR Text Key: 337185138
• Report Number: 2029046-2024-00767
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: 10846835002515
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P950005/S19
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BD7TCDF4L
• Device Lot Number: 30936131M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG