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

Catalog Number UNK_SMARTTOUCH BIDIRECT

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109); Pericardial Effusion (3271)

Event Date 03/31/2018

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source: safety and efficacy of minimal- versus zero-fluoroscopy radiofrequency catheter ablation for atrial fibrillation: a multicenter, prospective study.Pmid: 33262896 pmcid: pmc7685314 doi: 10.19102/icrm.2020.111105.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 provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source: safety and efficacy of minimal- versus zero-fluoroscopy radiofrequency catheter ablation for atrial fibrillation: a multicenter, prospective study.Pmid: 33262896 pmcid: pmc7685314 doi: 10.19102/icrm.2020.111105 adverse event(s) and provided interventions: it was reported that patients who underwent radiofrequency catheter ablation procedure with ablation catheter thermocool smarttouch surround flow has experienced transient ischemic attack, groin hematoma and pericardial effusion, without hemodynamic effect, all of which were managed conservatively.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13796789
• MDR Text Key: 287346666
• Report Number: 2029046-2022-00558
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTTOUCH BIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• 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: 0.32-IN GUIDEWIRE CATHETER - ABBOTT LABORATORIES; ACUSON ACUNAV; CARTO
• Patient Outcome(s): Other