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

Catalog Number SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Laceration(s) of Esophagus (2398)

Event Date 02/02/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.Literature citation: müller j, berkovitz a, halbfass p, nentwich k, ene e, sonne k, simu g, chakarov i, barth s, waechter c, behnes m, akin i, deneke t.Acute oesophageal safety of high-power short duration with 50 w for atrial fibrillation ablation.Europace.2022 feb 2:euab329.Doi: 10.1093/europace/euab329.Epub ahead of print.Pmid: 35134155.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.The literature file is too large to attach.Manufacturer's ref #: pc-(b)(4).

Event Description

This complaint is from a literature source.Literature citation: müller j, berkovitz a, halbfass p, nentwich k, ene e, sonne k, simu g, chakarov i, barth s, waechter c, behnes m, akin i, deneke t.Acute oesophageal safety of high-power short duration with 50 w for atrial fibrillation ablation.Europace.2022 feb 2:euab329.Doi: 10.1093/europace/euab329.Epub ahead of print.Pmid: 35134155.Objective/methods/study data: this study aims to investigate the safety of high-power short duration (hpsd) with emphasis on oesophageal lesions after pvi.Data includes patients undergoing af ablation at the posterior atrial wall y from april 2019 until january 2021.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf catheter concomitant other biosense webster devices that were also used in this study: carto concomitant non-biosense webster devices that were also used in this study: 11.7 french agilis sheath (st.Jude).Adverse event(s) and provided interventions possibly associated with ablation catheter: qty 58 endoscopically detected oesophageal lesion.Qty 1 patient developed osesophageal perforation 11 days after ablation with later subsequent atrio-esophageal fistula requiring operation.Qty 1 patient noted for steam pop (no details regarding patient consequence).

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14704992
• MDR Text Key: 294940117
• Report Number: 2029046-2022-01327
• Device Sequence Number: 1
• Product Code: LPB
• 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: 06/15/2022

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: SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/15/2022
• 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: 11.7 FRENCH AGILIS SHEATH (ST. JUDE); CARTO
• Patient Outcome(s): Required Intervention; Life Threatening