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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Paresis (1998); Laceration(s) of Esophagus (2398)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: list s, meinhardt c, mueller j, deneke t, barth s, waechter c, luesebrink u, elsaesser a, arlt a, halbfass p.Incidence of ablation-induced esophageal lesions and gastroparesis in patients undergoing ablation index guided high power short duration atrial fibrillation ablation.J cardiovasc electrophysiol.2023 jan;34(1):82-89.Doi: 10.1111/jce.15731.Epub (b)(6) 2022.Pmid: 36321661.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-01340 for product code unk_smart touch bidirectional sf.(2) mfr # 2029046-2023-01341 for product code unk_smart touch bidirectional sf.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: list s, meinhardt c, mueller j, deneke t, barth s, waechter c, luesebrink u, elsaesser a, arlt a, halbfass p.Incidence of ablation-induced esophageal lesions and gastroparesis in patients undergoing ablation index guided high power short duration atrial fibrillation ablation.J cardiovasc electrophysiol.2023 jan;34(1):82-89.Doi: 10.1111/jce.15731.Epub (b)(6) 2022.Pmid: 36321661.Objective/methods/study data:aim of this study was to evaluate the incidence of ablation-induced endoscopically detected esophageal lesions (edel) and gastroparesis in patients undergoing high-power short-duration (hpsd) atrial fibrillation (af) ablation using different target ablation index (ai) values.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: an irrigated ablation catheter (thermocool st sf catheter; biosense webster) other biosense webster devices that were also used in this study: three-dimensional (3d) electroanatomic mapping system (carto 3 v7; biosense webster) non-biosense webster devices that were also used in this study: adverse event(s) and provided interventions: 24/233 patients edel was documented no medical or surgical intervention noted gastroparesis was recorded in 22/233 patients no medical or surgical intervention noted all of the patients included in this study were clinically completely asymptomatic regarding clinical signs of esophageal injury during short-term follow up.In a 78-years old male patient a subdural hematoma was detected 34 days after the procedure while the patient was on oral anticoagulation with phenprocoumon.This patient underwent urgent cranial trepanation and recovered without any long-term sequelae.One patient had an ischemic stroke occurred 2 months after the ablation procedure.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17171637
• MDR Text Key: 317636975
• Report Number: 2029046-2023-01341
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• 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 V7, BIOSENSE WEBSTER.
• Patient Outcome(s): Life Threatening