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
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cardiac Tamponade (2226)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: wang k, jin c, chen h, yang g, liu h, wang z, jiang x, ju w, chen m.General anesthesia enhances lesion quality and ablation efficiency of circumferential pulmonary vein isolation.J arrhythm.2023 nov 27;40(1):76-82.Doi: 10.1002/joa3.12960.Pmid: 38333406; pmcid: pmc10848594.Objective/methods/study data: background: pulmonary vein isolation (pvi) is the cornerstone of atrial fibrillation (af) ablation.General anesthesia (ga) resolves the problem of pain intolerability and provides regular respiratory mode which might improve the catheter maneuverability of af ablation.This study aims to compare the procedural performance of pvi under ga versus conscious sedation (cs) from multiple perspectives.Methods: a total of 36 consecutive patients undergoing first af ablation under ga were enrolled in ga group.Another 109 patients receiving af ablation under cs in the same period were selected as the control group.After propensity score matching, 29 matched pairs with similar baseline characteristics were available for further analysis.The aifv (using ai to analyze the raw data from carto3 system) system was used to evaluate six procedural parameters in each pvi procedure.Results: compared with cs, pvi under ga had a significantly shorter total pvi time (51.4 min vs.67.8 min; p =.003) and higher radiofrequency ratio (62.6% vs.55.8%; p =.032).The number of gaps (1.0 vs.3.0; p <.001) and the rate of break point were significantly lower in the ga group.Ga was also associated with a higher effective ablation-index ratio (87.5% vs.74.1%; p <.001) and effective force-over-time ratio (85.3% vs.69.2%; p =.001).After a medium follow-up time of 24 months, 12/29 (41.4%) patients in the cs group and 6/29 (20.7%) patients in the ga group suffered from af recurrence (p =.156).Conclusions: ga improves the lesion quality and procedural efficiency of pvi from multiple perspectives evaluated by the aifv system.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch ablation catheter concomitant: biosense webster devices that were used in this study: pentaray mapping catheter, carto3 mapping system concomitant: non-biosense webster devices that were also used in this study: sl1 sheath (st.Jude medical) adverse event(s) and provided interventions possibly associated with unidentified smarttouch ablation catheter: qty 1 patient in the cs group suffered from pericardial tamponade, which resolved after pericardial drainage (cardiac tamponade)(recognized procedural complication) qty 2 transient episode of facial palsy and resolved after 20¿min which diagnosed to be a stroke by the magnetic resonance imaging (cerebrovascular accident)(recognized procedural complication).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: wang k, jin c, chen h, yang g, liu h, wang z, jiang x, ju w, chen m.General anesthesia enhances lesion quality and ablation efficiency of circumferential pulmonary vein isolation.J arrhythm.2023 nov 27;40(1):76-82.Doi: 10.1002/joa3.12960.Pmid: 38333406; pmcid: pmc10848594.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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: 18927506
• Report Number: 2029046-2024-00901
• Device Sequence Number: 9445750
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/18/2024

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 BIDIRECTIONAL
• 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: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: SL1 SHEATH ((B)(6) MEDICAL).; UNK_CARTO 3.; UNK_PENTARAY.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown