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

Catalog Number SMART TOUCH BIDIRECTIONAL SF

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: fakess, s., o' loughlin, m., tolat, a.Left ventricular thrombus following radiofrequency ventricular tachycardia ablation.Heart rhythm case reports 2022;-:1¿4).2022, march 24.Doi:https://doi.Org/10.1016/j.Hrcr.2022.03.013.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: fakess, s., o' loughlin, m., tolat, a.Left ventricular thrombus following radiofrequency ventricular tachycardia ablation.Heart rhythm case reports 2022;-:1¿4).2022, march 24.Doi:https://doi.Org/10.1016/j.Hrcr.2022.03.013.Objective/methods/study data: radiofrequency catheter ablation (rfca) has become a mainstay in the treatment of both atrial and ventricular tachyarrhythmias since first being developed in 1986.Over 235,000 ablation procedures are performed annually, with 7% of procedures being for ventricular tachycardia (vt) or premature ventricular contractions (pvc), a percentage that continues to grow.1 as experience in ablation techniques has grown, associated complications have become less common, but they remain an area of focus as the field advances.Thrombus formation is one such complication commonly associated with rfca, with an incidence of 0.6%¿0.8%, a risk that grows to 2.0% for the ablation of ventricular tachyarrhythmias.2 despite its being a relatively rare complication, the clinical sequelae of thrombus formation can be devastating, prompting a recent resurgence in the study of post-ablation thrombogenesis and treatment.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool stsf.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster concomitant devices that were also used in this study: baylis trans-septal needle.Adverse event(s) and provided interventions: a 43-year-old male patient developed a thrombus extending a length of 4.0 x 3.5 cm with a thickness of 0.6 cm post ablation, it was not present on the computed tomography performed prior to the procedure.Following this discovery, the patient was started on apixaban 5 mg twice daily for 1 month.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14795986
• MDR Text Key: 295069650
• Report Number: 2029046-2022-01422
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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
• Treatment: BAYLIS TRANS-SEPTAL NEEDLE
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male