MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Pleural Effusion (2010)

Event Date 11/25/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: chee j, kalogeropoulos ap, almasry i, singh a, rashba e, fan r.Identification and endocardial ablation of the ligament of marshall for pulmonary vein isolation.Jacc clin electrophysiol.2021 mar;7(3):283-291.Doi: 10.1016/j.Jacep.2020.08.027.Epub 2020 nov 25.Pmid: 33736749.Objective: wide antral ablation of the left pulmonary veins (pvs) may not achieve pvi, sometimes requiring empirical ablation of the pv carina.The mechanism could be due to epicardial conduction along the lom, which courses adjacent to the anterior carina.The aims of this study were to establish criteria for identifying ligament of marshall (lom) connections that are responsible for pulmonary vein isolation (pvi) failure, assess their incidence, and determine if they can be targeted by focal endocardial ablation at the anterior carina of the left superior pulmonary vein (lspv).Methods/study data: the study included 455 consecutive patients who underwent 570 procedures, of which 364 were first-time ablations for af between january 2013 and october 2019 by a single operator.Electroanatomic mapping was performed using either carto (biosense webster) or ensite navx (st.Jude medical) mapping systems.Intracardiac echocardiography guided double transseptal puncture was performed using an 8.5-f agilis steerable sheath (st.Jude medical) and an 8-f sl1 non-steerable sheath (st.Jude medical).A pentaray 20-pole mapping catheter (biosense webster) was used for mapping and recording of la and pv potentials.Rfa was performed using a 3.5-mm open irrigation ablation catheter, thermocool (biosense webster), thermocool smarttouch sf (biosense webster, irvine, california), or tacticath (st.Jude medical).Major complications of the 570 total procedures included 4 procedures with pericardial effusions requiring drainage and 1 procedure with a postprocedural stroke the evening following the procedure, with full neurological recovery.There were no clinical pv stenoses, atrioesophageal fistulas, or deaths.The authors used ablation catheters from 2 different manufacturers but did not provide information to associate the following adverse events with specific device manufacturers.The actual number of bwi devices associated with these events is unknown.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool, thermocool smarttouch sf.Other biosense webster devices that were also used in this study: carto 3 electronic mapping system, pentaray 20-pole mapping catheter.Non-biosense webster devices that were also used in this study: tacticath (st.Jude medical), ensite navx (st.Jude medical), 8.5-f agilis steerable sheath (st.Jude medical), 8-f sl1 non-steerable sheath (st.Jude medical).Adverse event(s) and provided interventions: 4 pericardial effusions treated with drainage, 1 periprocedural stroke- treatment not specified.Patient experienced full neurological recovery.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: chee j, kalogeropoulos ap, almasry i, singh a, rashba e, fan r.Identification and endocardial ablation of the ligament of marshall for pulmonary vein isolation.Jacc clin electrophysiol.2021 mar;7(3):283-291.Doi: 10.1016/j.Jacep.2020.08.027.Epub 2020 nov 25.Pmid: 33736749.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.Manufacturer's reference number: (b)(4).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12585613
• MDR Text Key: 281850038
• Report Number: 2029046-2021-01691
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8-F SL1 NON-STEERABLE SHEATH (ST. JUDE MEDICAL); 8.5-F AGILIS STEERABLE SHEATH (ST. JUDE MEDICAL); CARTO 3 ELECTRONIC MAPPING SYSTEM; ENSITE NAVX (ST. JUDE MEDICAL); PENTARAY 20-POLE MAPPING CATHETER; TACTICATH (ST. JUDE MEDICAL)
• Patient Outcome(s): Life Threatening; Required Intervention