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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)

Event Date 09/17/2021

Event Type  Injury  

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 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
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12613431
• MDR Text Key: 275875572
• Report Number: 2029046-2021-01737
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835002874
• UDI-Public: 10846835002874
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BDI75TCDFRT
• Device Catalogue Number: BDI75TCDFRT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening