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 Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: petr peichi, alan bulava, dan wichterie; predrag stojadinovic; eva borisincova; peter stiavnick y; jana ha skov a; robert cih ak and josef kautzner.(may 2024).Acute efficacy and safety of pulsed field ablation for ventricular arrhythmia: twocenter experience.Heart rhythm, vol 21, no5s.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: petr peichi, alan bulava, dan wichterie; predrag stojadinovic; eva borisincova; peter stiavnick y; jana ha skov a; robert cih ak and josef kautzner.(may 2024).Acute efficacy and safety of pulsed field ablation for ventricular arrhythmia: twocenter experience.Heart rhythm, vol 21, no5s.Objective/methods/study data: [background: a novel pulsed field (pf) energy source is a potential option for catheter ablation of ventricular arrhythmias (va) as it can create deeper lesions, particularly in scarred tissue.However, only limited data exist regarding its efficacy and safety.Objective: this study presents the initial experience with va ablation using pf.Methods: the study group consisted of 31 patients (11 women, aged: 61616years) with either frequent ventricular ectopy (39%) or sustained va (61%).A total of 58% of patients had failed previous radiofrequency ablation of va.The mean lv ejection fraction was 42614%.Ablation was performed using an irrigated 4-mm tip catheter (thermocool smarttouchtm, biosensewebster, inc.) in combination with a commercially available pf generator (centauritm, galvanize therapeutics, inc.).Results: on average, 18617 pf applications (25a) were delivered per patient.In 7 patients (23%), an additional rf ablation (469 applications) was performed.Acute success was achieved in 81% of patients as assessed by non-inducibility of va or elimination of ectopic focus.However, 3 cases (10%) experienced transient conduction system block during pf application on the lateral lv wall remotely from the lv septum.Complete av block occurred in one patient, while lbbb occurred in two patients.Importantly, these events were observed only when using the retrograde approach with the proximal electrodes on the shaft of the ablation catheter positioned near the his region (figure).This may be due to current leakage through these electrodes.Fortunately, all observed conduction disturbances resolved in all cases within one hour.Conclusion: initial experience with pf treatment for va has shown high efficacy in the short term.However, its long-term effects are yet to be determined.It is important to note that certain catheter positions while using this ablation system may lead to unexpected adverse events.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Concomitant biosense webster devices that were used in this study: n/a concomitant non-biosense webster devices that were also used in this study: centauri pf generator.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch: qty 1 ¿ (heart block av) (recognized procedural complication) which resolved within one hour (off label use- pec).Nonserious event(s) and provided interventions possibly associated with unidentified thermocool smarttouch: qty 2 ¿ (arrhythmia)(recognized procedural complication) which resolved within one hour(off label use- pec).

• 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: 19619330
• Report Number: 2029046-2024-02101
• Device Sequence Number: 6954471
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (Y/N): N
• 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: Foreign,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: 05/31/2024
• 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: CENTAURI PF GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown