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 Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Ischemia Stroke (4418); Heart Block (4444); Unspecified Tissue Injury (4559)

Event Date 05/15/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: bates a, naseer m, taylor m, denham n, yue a, das m, morris gm, ullah w.A u.K.Multicenter retrospective study of the learning curve and relative impact on success rates and procedural metrics of the rhythmia hdx¿ mapping system.J innov card rhythm manag.2023 may 15;14(5):5442-5450.Doi: 10.19102/icrm.2023.14054.Pmid: 37216082; pmcid: pmc10193869.Objective/methods/study data: abstract: the learning curve for the novel rhythmia hdx¿ 3-dimensional electroanatomic system is unknown.Retrospective data collection was carried out at 3 u.K.Centers from the introduction of rhythmia hdx¿ (boston scientific, marlborough, ma, usa) and associated mapping and ablation catheters.Patients were matched with controls using the carto® 3 mapping system (biosense webster inc., diamond bar, ca, usa).Fluoroscopy, radiofrequency ablation, and procedure times; acute and long-term success; and complications were assessed.A total of 253 study patients along with 253 controls were included.Significant correlations existed between procedural efficiency metrics and center experience for de novo atrial fibrillation (af) ablation (procedure time, spearman's = -0.624; ablation time, = -0.795; both p <.0005) and de novo atrial flutter (afl) ablation (ablation time, = -0.566; fluoroscopy time, = -0.520; both p =.001).No correlations existed for other assessed atrial arrhythmias.For de novo af and afl, metrics significantly improved after 10 procedures in each center (procedure time [af only, p =.001], ablation time [af, p <.0005; afl, p <.0005], and fluoroscopy time [afl only, p =.0022]) and became comparable to those of controls.Acute success and long-term success did not experience significant improvements with experience, but they were comparable to the control group throughout.Complications with rhythmia hdx¿ were comparable to those associated with carto® 3.In conclusion, a short learning curve exists with the use of rhythmia hdx¿ for standardized procedures (de novo af/afl).Procedural performance improved and became comparable to that seen with carto® 3 following 10 cases at each center.Clinical outcomes at 6 and 12 months and complications were no different from those observed in controls.Concomitant biosense webster devices that were used in this study: carto3 non-biosense webster devices that were also used in this study: rhythmia hdx mapping system (boston scientific) the article reports all mapping and ablation catheters used with the carto3 system were manufactured by biosense webster and all mapping and ablation catheters used with rhythmia were manufactured by boston scientific.However, the article does not provide the specific names/identity of the catheters.Carto3 is a mapping software system that is used in conjunction with vascular devices.Therefore, an unknown thermocool smarttouch ablation catheter is being utilized to capture the adverse events within the carto3 group until further information is provided by the author(s).Hematomas are associated with sheaths and the article does not discuss sheaths utilized for procedure.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 1 (cardiac arrest) due to (cardiac tamponade) from a tear in the coronary sinus (soft tissue injury).This was repaired by emergency cardiac surgery (surgical intervention) and resulted in an anoxic brain injury (cerebral infarction) reported by narrative description.It is noted that table 4 captures the event as left atrial appendage dissection.Qty 1 complete atrioventricular block (heart block av) that required permanent pacing device the following day (surgical intervention) reported by narrative description.It is noted that table 4 captures the event as bradycardia requiring permanent pacing.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: bates a, naseer m, taylor m, denham n, yue a, das m, morris gm, ullah w.A u.K.Multicenter retrospective study of the learning curve and relative impact on success rates and procedural metrics of the rhythmia hdx¿ mapping system.J innov card rhythm manag.2023 may 15;14(5):5442-5450.Doi: 10.19102/icrm.2023.14054.Pmid: 37216082; pmcid: pmc10193869.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
• 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: 18927521
• MDR Text Key: 337945951
• Report Number: 2029046-2024-00902
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• 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
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: CARTO3; RHYTHMIA HDX MAPPING SYSTEM (BOSTON SCIENTIFIC)
• Patient Outcome(s): Required Intervention; Life Threatening