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

Catalog Number	UNK_SMART TOUCH UNIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: kurata m, batnyam u, tedrow ub, richardson td, kanagasundram an, hasegawa k, uetake s, manuelian d, pellegrini c, stevenson wg.Intramural needle ablation or repeated standard ablation in patients referred for repeat ablation of scar-related ventricular tachycardia.J cardiovasc electrophysiol.2024 may;35(5):994-1004.Doi: 10.1111/jce.16250.Epub 2024 mar 19.Pmid: 38501333.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.Manufacturer's ref #: (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: kurata m, batnyam u, tedrow ub, richardson td, kanagasundram an, hasegawa k, uetake s, manuelian d, pellegrini c, stevenson wg.Intramural needle ablation or repeated standard ablation in patients referred for repeat ablation of scar-related ventricular tachycardia.J cardiovasc electrophysiol.2024 may;35(5):994-1004.Doi: 10.1111/jce.16250.Epub 2024 mar 19.Pmid: 38501333.Objective/methods/study data: introduction: when ventricular tachycardia (vt) recurs after standard rf ablation (srfa) some patients benefit from repeat srfa, whereas others warrant advanced methods such as intramural needle ablation (ina).Our objectives are to assess the utility of repeat srfa and to clarify the benefit of ina when repeat srfa fails in patients with vt due to structural heart disease.Methods: in consecutive patients who were prospectively enrolled in a study for ina for recurrent sustained monomorphic vt despite srfa, repeat srfa was considered first.Ina was performed during the same procedure if repeat srfa failed or no targets for srfa were identified.Results: of 85 patients enrolled, acute success with repeat srfa was achieved in 30 patients (35%), and during the 6-month follow-up, 87% (20/23) were free of vt hospitalization, 78% were free of any vt, and 7 were lost to follow-up.Ina was performed in 55 patients (65%) after srfa failed, or no endocardial targets were found abolished or modified inducible vt in 35/55 patients (64%).During follow-up, 72% (39/54) were free of vt hospitalization, 41% were free of any vt, and 1 was lost to follow-up.Overall, 59 out of 77 (77%) patients were free of hospitalization and 52% were free of any vt.Septal-origin vts were more likely to need ina, whereas rv and papillary muscle vts were less likely to require ina.Conclusions: repeat srfa was beneficial in 23% (18/77) of patients with recurrent sustained vt who were referred for ina.The availability of ina increased favorable outcomes to 52%.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool® smarttouch¿ femoral bleeding or access complication occurred, therefore non-bwi sheath was reported.Concomitant biosense webster devices that were used in this study: soundstar, carto 3 system, pentaray® nav, decanav concomitant non-biosense webster devices that were also used in this study: recording system (ge medical, inc) adverse event(s) and provided interventions possibly associated with unidentified thermocool® smarttouch¿ in the standard rfa: qty 1: one patient developed a pericardial effusion following a steam pop at the basal lateral mitral annulus lv requiring surgical repair.(cardiac tamponade) (surgical intervention) (steam pop) (adverse event).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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: 19620499
• Report Number: 2029046-2024-02104
• Device Sequence Number: 8085170
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RECORDING SYSTEM (GE MEDICAL, INC); UNK_C3 CS REFSTAR - DEFLECTABLE; UNK_CARTO 3; UNK_PENTARAY; UNK_SOUNDSTAR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown