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

Model Number D-1197-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)

Event Date 12/31/2013

Event Type  Injury  

Manufacturer Narrative

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 no lot number was provided by the customer.Since the lot number is unknown, the full udi number cannot be provided.Concomitant products that were used during this study: carto; acunav 8f 64-element phased-array intracardiac echocardiography catheter.Other company¿s devices that were used during this study: bard transvenous 6f quadripolar catheter; boston scientific bi-directional closed irrigated ablation catheter (b)(4).The device was not returned.

Event Description

This complaint is from a literature source.It was reported that two patients underwent radiofrequency catheter ablation for ventricular tachycardia (vt) and suffered post-procedural deep vein thrombosis with pulmonary embolism requiring anticoagulant therapy.After these two thrombotic events, intravenous heparin therapy was routinely used for 48 hours after all pericardial drains were removed.Title: "long-term outcome with catheter ablation of ventricular tachycardia in patients with arrhythmogenic right ventricular cardiomyopathy" the purpose of this study was to determine the long-term outcomes of vt control and need for anti-arrhythmic drug therapy after endocardial and adjuvant epicardial substrate modification in patients with arrhythmogenic right ventricular cardiomyopathy.Suspected device is navistar thermocool ablation catheter.Concomitant products that were used during this study: carto; acunav 8f 64-element phased-array intracardiac echocardiography catheter.Other company's devices that were used during this study: bard transvenous 6f quadripolar catheter; boston scientific bi-directional closed irrigated ablation catheter.The awareness date for this complaint is 4/14/2016 because the article was reviewed on 4/14/2016.

Manufacturer Narrative

Additional information was received from author on june 07 2016: the cause of reported deep venous thrombosis complications were related to long procedure.One of the two patients who suffered deep venous thrombosis was required inferior vena cava filter.Both patients were anticoagulated.All patients were required extended hospitalization and fully recovered.All patients had arrhythmogenic right ventricular cardiomyopathy and recurrent drug refractory ventricular tachycardia.The event did not result in the impairment of a body function or damage to a body structure.All complications were recognized risks associated with the vt ablation procedure.No complication was related to thermocool catheter.Patient demographic information: female, (b)(6); female, (b)(6).

• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5632934
• MDR Text Key: 44452520
• Report Number: 2029046-2016-00041
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• 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 Catalogue Number: D119700
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 66