MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031

Model Number D-1197-00

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 10/01/2011

Event Type  Injury  

Manufacturer Narrative

Concomitant products: carto mapping system; parahis catheter." device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Concomitant bwi products: product: carto¿ xp system, us catalog # fg-4700-00, serial # unknown.Product: parahis catheter, us catalog # unknown, lot # unknown.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

This complaint is from literature source.The patient with successful substrate isolation developed pericardial effusion during the index procedure, requiring subxiphoidal epicardial drainage.Multiple attempts have been made to obtain the adverse event questionnaire of this complaint.As for now, no further information has been made available.This adverse event is determined to be mdr reportable.Article title: ¿electrical isolation of a substrate after myocardial infarction: a novel ablation strategy for un-mappable ventricular tachycardias-feasibility and clinical outcome¿.Per a report of europace.2014 july, a single-center study was conducted on 12 patients, from (b)(6) 2007 and (b)(6) 2011.The aim of this study was to assess if isolation of the arrhythmogenic substrate would be a feasible and effective ablation strategy for the treatment of ischaemic vt.Median follow-up of 479 (297; 781) days.From the report there were total of 3 serious adverse events: (all these events will be reported separately).One patient with successful substrate isolation developed pericardial effusion during the index procedure, requiring subxiphoidal epicardial drainage.One patient developed pneumonia 1 day after the index ablation without general anaesthesia which was successfully treated with intravenous antibiotics.Only one patient developed lv thrombus, which remained despite therapeutic oral anticoagulation during follow-up.Importantly, no symptomatic thromboembolic events occurred.There are 4 death events reported: (these deaths events will be reported separately) four patients died 304 (q1; q3, 166; 445) days after the index procedure: two patient died due to heart failure; one patient died due to sepsis; one patient committed suicide.Relationship to device or procedure was not provided.No device malfunction was reported in the publication.Model and catalog number are not available, but the suspected device is the navistar thermocool c.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: SIMILAR DEVICE NI75TCJH, PMA # P030031
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4124740
• MDR Text Key: 19372805
• Report Number: 2029046-2014-00341
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2014

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: D-1197-00
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2014
• Initial Date FDA Received: 09/29/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR