MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Cardiac Perforation (2513)

Event Date 08/31/2019

Event Type  Injury  

Event Description

This complaint is from a literature source: potter t, herendael hv, balasubramaniam r, wright m, latcu dg, agarwal sc, zhang b, boo lm, pani a.Safety and long-term success of persistent atrial fibrillation ablation using thermocool smarttouch® catheter: real-world experience.J atr fibrillation.2019 aug 31;12(2):2126.Doi: 10.4022/jafib.2126.Pmid: 32002110; pmcid: pmc6990050.Objective/methods/study data: to investigate the real-world clinical experience of persistent atrial fibrillation (persaf) ablation using the thermocool smarttouch® catheter with contact force (cf)-sensing ability in a prospective, multicenter registry.The thermocool smarttouch® registry, a prospective, open-label, multicenter, observational registry, was designed to evaluate the real-world safety and long-term success of persaf ablation using an open-irrigated, cf-sensing catheter (thermocool smarttouch® catheter; biosense webster, inc., diamond bar, california).Data were collected between august 30, 2012, and june 28, 2014, at 24 centers in europe, australia, and canada.An institutional review board and/or ethics committee approved the study at each participating center.The study was conducted in accordance with the declaration of helsinki and the international conference on harmonisation harmonised tripartite guidelines for good clinical practice.All patients provided written informed consent to the study protocol.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 7.5-fr thermocool smarttouch® cf-sensing catheter other biosense webster concomitant devices that were also used in this study: carto® 3 system (biosense webster, inc., diamond bar, california).Non-biosense webster devices that were also used in this study: n /a.Adverse event(s) and provided interventions: qty 1 cardiac perforation-the case of cardiac perforation occurred at the time of mapping, and no rf energy was delivered.Qty 1 atrioesophageal fistula- the atrioesophageal fistula case resulted in death 1 month after the index ablation procedure and was considered procedure related and possibly device related.After discharge, this patient presented to a different institution with pulmonary symptoms and was diagnosed with an atrioesophageal fistula.The patient¿s ablation procedure, which involved pvi with additional ablation of non-pv targets, was performed under general anesthesia without the use of esophageal probe or esophageal preimaging by an investigator who had previous experience with the study catheter.The patient had no significant comorbidities, and ablation parameters were within normal limits.Qty 1 stroke.

Manufacturer Narrative

This complaint is from a literature source: potter t, herendael hv, balasubramaniam r, wright m, latcu dg, agarwal sc, zhang b, boo lm, pani a.Safety and long-term success of persistent atrial fibrillation ablation using thermocool smarttouch® catheter: real-world experience.J atr fibrillation.2019 aug 31;12(2):2126.Doi: 10.4022/jafib.2126.Pmid: 32002110; pmcid: pmc6990050.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The ¿suspected medical device¿ reported of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02465 for unknown product code (2) mfr # 2029046-2022-02466 for unknown product code.

Manufacturer Narrative

During internal review of this report, it was discovered that incorrect information was provided.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).The below information provided is incorrect, this device is marketed in the us.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 15573740
• MDR Text Key: 301641439
• Report Number: 2029046-2022-02466
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 10/10/2022

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 Catalogue Number: UNK_SMART TOUCH UNIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/31/2023
• 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: CARTO® 3 SYSTEM (BIOSENSE WEBSTER)
• Patient Outcome(s): Life Threatening