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

Model Number D132701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Myocardial Infarction (1969); Pain (1994); Vasoconstriction (2126); Ischemic Heart Disease (2493); Thrombosis/Thrombus (4440)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: du x, wang s, he b, chu h.Coronary injury caused by endocardial ablation in midanterior septum of the right ventricle.Jacc case rep.2022 nov 3;4(24):101628.Doi: 10.1016/j.Jaccas.2022.08.042.Pmid: 36684028; pmcid: pmc9847231.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 Description

This complaint is from a literature source.The following literature cite has been reviewed: du x, wang s, he b, chu h.Coronary injury caused by endocardial ablation in midanterior septum of the right ventricle.Jacc case rep.2022 nov 3;4(24):101628.Doi: 10.1016/j.Jaccas.2022.08.042.Pmid: 36684028; pmcid: pmc9847231.Objective and methods: coronary injury or spasm induced by endocardial radiofrequency catheter ablation in the right ventricle (rv) has been rarely reported.The article resents a case of coronary injury from a young, 24-year-old female patient who underwent catheter ablation for idiopathic ventricular arrhythmia originating from the rv septum.Immediately after ablation, the patient complained of chest pain and the ecg revealed st elevations in the anteroseptal leads.A transfemoral coronary angiography revealed acute occlusion of the mid-distal segment of the lad artery due to vasospasm.The patient received and intracoronary injection of nitroglycerin and verapamil via microcatheter to restore blood flow.The thrombolysis in myocardial infarction grade 3 were resolved after transluminal coronary angioplasty balloon dilation of the lad.Post angioplasty blood tests identified a transient elevation of troponin i at a peak value of 2.51 ng/ml.The patient was put on a one-month regimen of antiplatelet therapy of aspirin and clopidogrel.Postprocedural ecg showed normal sinus rhythm.4 weeks after the incident, the patient again presented with transient st elevations secondary to a coronary artery spasm.No abnormalities were identified on repeat angiogram.The patient was treated with nicorandil.No further coronary artery spasms were identified in follow-up.Fluoroscopic imaging: fig.1 and fig 2.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool smarttouch ablation catheter.Other biosense webster devices that were also used in this study: na.Non-biosense webster devices that were also used in this study: na.Adverse event(s) and provided interventions: chest pain, myocardial infarction, vasospasm of coronary artery, and thrombosis treated with balloon angioplasty and oral medication.The second coronary artery spasm is considered a continuation of the thermal injury to the lad incurred during the initial ablation procedure.

• 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: 16461773
• MDR Text Key: 310455611
• Report Number: 2029046-2023-00420
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/01/2023

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
• Device Operator: Health Professional
• Device Model Number: D132701
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 03/01/2023
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 24 YR
• Patient Sex: Female