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

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

This complaint is from a literature source (abstract).The following literature abstract citation has been reviewed: mavilakandy a, antoun i, kotb a, et al95 safety and outcomes of very high-power short-duration ablation using 90w for pulmonary vein isolation in patients with atrial fibrillation: a real world observation studyheart 2022;108:a71-a72.Objective/methods/study data: the aim of this study was to compare procedural outcomes of the novel contact force-sensing temperature-controlled very high-power short-duration (vhpsd) rf ablation and safety with conventional radiofrequency ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: qdot micro catheter, thermocool smarttouch sf.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions (for qdot micro catheter): qty 1 cardiac tamponade.Adverse event(s) and provided interventions (for thermocool smarttouch sf): qty 1 embolic stroke.Qty 2 pericardial effusions that did not require drainage.

Manufacturer Narrative

This complaint is from a literature source (abstract).The following literature abstract citation has been reviewed: mavilakandy a, antoun i, kotb a, et al95 safety and outcomes of very high-power short-duration ablation using 90w for pulmonary vein isolation in patients with atrial fibrillation: a real world observation studyheart 2022;108:a71-a72.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 the lot number was not provided by the customer.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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 ; 646591-798
• MDR Report Key: 15317708
• MDR Text Key: 298873048
• Report Number: 2029046-2022-02037
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• 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
• Patient Outcome(s): Life Threatening