MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation 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 was performed for the finished device 30533502m number, and no internal action related to the complaint was found during the review if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a ventricular tachycardia (vt) ablation procedure with an ez steer" thermocool¿ nav bi-directional catheter and the patient suffered heart block av requiring temporarily pacing wire to be inserted and planning for a cardiac resynchronization therapy with defibrillation (crt-d).During a vt ablation when tachycardia was stopped, av block was present.A temporary pacemaker was inserted.The physician commented that originally, there were several types of vt, and today's vt is close to his, so i just need to stop the tachycardia.This adverse event was discovered during use of biosense webster products.The physicians opinion on the cause of this adverse even was that it was patient condition related.The origin of the vt was close to his-bundle.Patient outcome was reported as improved.It was not reported that extended hospitalization was required.

• Brand Name: EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12192923
• Report Number: 2029046-2021-01150
• Device Sequence Number: 1390560
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 04/21/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30533502M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR