MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	UNK_SMART TOUCH BIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: john rm, tedrow u, tadros t, richardson td, kanagasundram a, hoffman rd, kapp me, shah a, michaud g, stevenson w.Intramyocardial hematoma during catheter ablation for scar-related ventricular tachycardia.Jacc clin electrophysiol.2023 aug 11:s2405-500x(23)00516-9.Doi: 10.1016/j.Jacep.2023.07.004.Epub ahead of print.Pmid: 37632506.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).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: john rm, tedrow u, tadros t, richardson td, kanagasundram a, hoffman rd, kapp me, shah a, michaud g, stevenson w.Intramyocardial hematoma during catheter ablation for scar-related ventricular tachycardia.Jacc clin electrophysiol.2023 aug 11:s2405-500x(23)00516-9.Doi: 10.1016/j.Jacep.2023.07.004.Epub ahead of print.Pmid: 37632506.Objective/methods/study data:the goal of this study was to describe the features and outcomes of intramural hematoma during ablation for scar-related vt.Three of the four cases involved biosense webster products.Adverse event(s) and provided interventions case #1 possibly associated with unidentified biosense webster df curve st/sf (contact force sensing): qty 1 basal inferolateral left ventricle hematoma (hematoma) treated with pericardiocentesis, emergency sternotomy and procoagulant collagen patch (surgical intervention).Patient outcome is discharged.Adverse event(s) and provided interventions case #2 possibly associated with unidentified biosense webster thermocool df curve st (contact force sensing): qty 1 mid to distal lateral left ventricle hematoma (hematoma) treated with pericardiocentesis, emergency sternotomy, hematoma unroofed, hemostasis, bioglue and pericardial patch repair; aortic valve replacement for aortic stenosis ; left ventricle assist device for 1 week and procoagulant collagen patch (surgical intervention).Patient outcome is discharged.Adverse event(s) and provided interventions case #3 possibly associated with unidentified biosense webster thermocool celsius irrigated rf catheter): qty 1 anterolateral left ventricle hematoma (hematoma) treated conservatively (minor injury).Patient outcome is discharged.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION 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: 17951079
• Report Number: 2029046-2023-02341
• Device Sequence Number: 15153449
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• 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): 10/17/2023

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: 09/20/2023
• Initial Report FDA Received Date: 10/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown