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); Dyspnea (1816)

Event Date 10/30/2014

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.Concomitant products were used during this study: carto 3 system and a spiral diagnostic decapolar mapping lasso catheter.Other company¿s devices were used during this study: sl1 sheaths (st.Jude medical, minneapolis, mn, usa).(b)(4).The device was not returned to bwi.

Event Description

This event is from a literature source.It was reported that one patient developed pulmonary embolism, the anticoagulation regimen after the ablation procedure was followed according to our protocol (rivaroxaban group).The patient complained of dyspnea the day after the procedure.Diuretic therapy was initiated as pulmonary congestion was suggested as the cause for dyspnea.As the symptoms did not resolve, a ct-scan was performed on the 4th day after the ablation procedure, with confirmation of pulmonary embolism.Since then, the patient was treated with rivaroxaban 15 mg b.I.D.According to the current recommendations.Based on the facts of the case and the author's assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title:apixaban, rivaroxaban, and dabigatran in patients undergoing atrial fibrillation ablation.The purpose of this study was to evaluate the periprocedural major complications (mc) of ca of af, and compared apixaban, dabigatran, and rivaroxaban with continuous phenoprocoumon.The study was conducted between october 2013 and october 2014.Suspected device is the thermocool navi-star catheter, however catalog and lot number are unknown.Should more information be received, product for this adverse event will be modified as appropriate.Concomitant products were used during this study: carto 3 system and a spiral diagnostic decapolar mapping lasso catheter.Other company's devices were used during this study: sl1 sheaths (st.Jude medical, minneapolis, mn, usa).

• 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: 5981125
• MDR Text Key: 55790771
• Report Number: 2029046-2016-00135
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/07/2016

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 Catalogue Number: D119700
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR