MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/31/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: dhillon g, honarbakhsh s, abbas h, waddingham p, dennis as, ahluwalia n, finlay m, sohaib a, welch s, daw h, sporton s, chow a, earley mj, lambiase pd, hunter rj.Ecgi targeted ablation for persistent af not responding to pulmonary vein isolation: results of a two-staged strategy (target af2).Heart rhythm o2.2023 aug 31;4(10):609-617.Doi: 10.1016/j.Hroo.2023.08.004.Pmid: (b)(4); pmcid: (b)(4).Objective/methods/study data: background: mechanisms sustaining persistent atrial fibrillation (af) remain unclear.Objectives: the study sought to evaluate both the clinical outcomes and response to ablation of potential drivers in patients with recurrent persistent af recurrence following pulmonary vein isolation (pvi).Methods: a total of 100 patients with persistent af of <2 years' duration underwent cryoballoon pvi (ecgi phenotyping of persistent af based on driver burden and distribution to predict response to pulmonary vein isolation).Patients with documented recurrence of atrial arrhythmia within 12 months were recruited and underwent repeat pvi (if needed) followed by ablation of potential drivers (pds) identified by electrocardiographic imaging (ecgi).Pds were defined as rotational activity >1.5 revolutions or focal activations.Cycle lengths were measured pre- and postablation.The primary outcome was freedom from atrial arrhythmia off antiarrhythmic drugs at 1 year as per guidelines.Results: of 37 patients recruited, 26 had recurrent af and underwent ecgi-guided ablation of pds.An average of 6.4 ± 2.7 pds were targeted per patient.The mean ablation time targeting pds was 15.5 ± 6.9 minutes.An ablation response occurred in 20 patients (af termination in 6, cycle length prolongation =10% in 14).At 1 year, 14 (54%) of 26 patients were free from arrhythmia, and 12 (46%) of 26 were off antiarrhythmic drugs.Considering the 96 patients who completed follow-up out of the original cohort of 100 patients undergoing cryoablation in this staged strategy, freedom from arrhythmia at 1 year following the last procedure was 72 (75%) of 96, or 70 (73%) of 96 off antiarrhythmic drugs.Conclusions: in patients with recurrent af despite pvi, ecgi-guided ablation caused an acute response in a majority with reasonable long-term outcomes.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter.Concomitant biosense webster devices that were used in this study: carto3 mapping system, pentaray mapping catheter.Concomitant non-biosense webster devices that were also used in this study: labsystem pro recording system (boston scientific).Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 1 pericardial effusion that required percutaneous drainage (cardiac tamponade)(recognized procedural complication).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: dhillon g, honarbakhsh s, abbas h, waddingham p, dennis as, ahluwalia n, finlay m, sohaib a, welch s, daw h, sporton s, chow a, earley mj, lambiase pd, hunter rj.Ecgi targeted ablation for persistent af not responding to pulmonary vein isolation: results of a two-staged strategy (target af2).Heart rhythm o2.2023 aug 31;4(10):609-617.Doi: 10.1016/j.Hroo.2023.08.004.Pmid: (b)(4); pmcid: (b)(4).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 not 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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 18937578
• MDR Text Key: 338069681
• Report Number: 2029046-2024-00926
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• 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: UNK_CARTO 3; UNK_LABSYSTEM PRO RECORDING SYSTEM; UNK_PENTARAY
• Patient Outcome(s): Required Intervention; Life Threatening