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

Model Number	BD7TCFJ4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient ((b)(6)1948) underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a ez steer¿ bi-directional electrophysiology catheter.The patient suffered heart block requiring surgical intervention.It was reported that during an avnrt case, it was noticed that there was complete heart block in the patient.They could not stop the arrhythmia, and while the catheter was moving, the impedance was stable.When the physician decided to come off ablation, it was then noticed that the patient had complete heart block on the recording system.The patient was then administered two different steroids--the specific dosage or drug information is not available to bwi.The patient had a temporary pacemaker implanted.The patient was reported to be in stable condition.The physician does not believe the complete heart block was a result of ablation, rather that the patient had av node conduction disease.The physician believes that they had ablated the slow pathway, but that the patient was "sickly" to begin with, and the physician believes it's possible that the patient's slow pathway was the only pathway they had left.Patient outcome of the adverse event is unknown and the bwis sales consultant is unsure if the patient required extended hospitalization.A generator with serial number (b)(4) was used.The 4mm ablation catheter is not available for return.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 and mdr-reportable.
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15359168
• Report Number: 2029046-2022-02111
• Device Sequence Number: 5227480
• Product Code: LPB
• UDI-Device Identifier: 10846835002584
• UDI-Public: 10846835002584
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2022

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 Model Number: BD7TCFJ4L
• Device Catalogue Number: BD7TCFJ4L
• 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: 08/10/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male