MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Thrombosis/Thrombus (4440)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported that an unknown male patient in his 30s underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered thrombosis and cardiac arrest requiring cpr and extended hospitalization.It was reported that the patient coded in the middle of the atrial flutter case.The ultrasound did not show an effusion, the blood pressure was dropping but everything came back up.During the case it was noted that the patient was on a pulseless electrical activity (pea).Cpr was immediately provided, and the ultrasound showed tiny clots on the right atrium after cpr, this could have been the reason for the event.The bwi company representative stated that all of this is just speculation, as the physician is not sure why this happened, but it could be due to a prior underlying condition the patient has.The patient is in stable condition at this time.The following catheter was used during the ablation portion of the case, which was completed successfully.Intervention provided was cpr, medication, and the patient required extended hospitalization.The length of the extended hospitalization is unknown at the time.The patient outcome of the adverse event is stable and improved.Other relevant history: ejection fraction (ef) was around 10-15% and patient had heart failure.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.

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.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: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 ; 6465917981
• MDR Report Key: 14137759
• MDR Text Key: 289688985
• Report Number: 2029046-2022-00835
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2022

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
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male