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

Model Number	BDI75TCDFRT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore 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.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 male patient underwent a ventricular tachycardia (vt) ablation procedure with a ez steer¿ thermocool® bi-directional catheter.The patient suffered a mild thromboembolic event.Customer informed us three days after the procedure that the patient had a mild thromboembolic event after an intensive vt ablation in the left ventricle.They don¿t think it is related to the product but more to the patient condition.In the meantime the patient is fine again and there are no further consequences.There was no post-op device malfunction.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event: patient condition.It is unknown if intervention was required.Patient outcome was reported as fully recovered.Prolonged hospitalization is unknown.Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• Brand Name: EZ STEER THERMOCOOL 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: 12613431
• Report Number: 2029046-2021-01737
• Device Sequence Number: 13806534
• Product Code: OAD
• UDI-Device Identifier: 10846835002874
• UDI-Public: 10846835002874
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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 Model Number: BDI75TCDFRT
• Device Catalogue Number: BDI75TCDFRT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/12/2021
• 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: Life Threatening