MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; SIMILAR DEVICE D131801, PMA # P030031/S034

Model Number D-1318-00

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 09/01/2013

Event Type  Injury  

Event Description

In an article which biosense webster already reported under report # 9673241-2014-00312 on (b)(6) 2014, after investigation on (b)(6) 2014, the author of the article mentioned, that (b)(6) male experienced cerebrovascular accident.There is no more additional information.Therefore this report will be submitted to document this patient¿s specific injury.In addition there were serious adverse events (these events will be reported separately): patient # 1 ((b)(6)): transient ischemic attack, patient # 3 ((b)(6)): pericardial effusion, patient # 5 ((b)(6)): pericardial effusion, patient # 8 ((b)(6)): cerebrovascular accident, patient # 9 ((b)(6)): pericardial effusion, patient #10 ((b)(6)): pericardial effusion.There are other non-serious ae¿s events: patient # 2: hematoma, patient # 4: hematoma, patient # 6: hematoma, patient # 7: hematoma.There were no device malfunctions reported in the publication.The original article: article title: safety of new oral anticoagulants for patients undergoing atrial fibrillation ablation.Per a report in the journal j interv card electrophysiol (2014) 40:33¿38, a retrospective analysis on 301 patients who were referred for cardiac ablation of af between january 2011 and september 2013 by dr.Stepanyan, division of cardiology, department of medicine, university of california, san francisco et al., to evaluate the risk of bleeding and te complications associated with new oral anticoagulants (noac), dabigatran and rivaroxaban, noac use during af ablation.Followed up for at least 30 days for procedural complications.

Manufacturer Narrative

(b)(4).From the report there were two thromboembolism events, one case of multiple cerebral emboli detected on ct in a patient with vertigo following ablation and one tia.There were 17 bleeding events (large hematoma n=4; pericardial effusion n=6.(of the six pericardial effusions, three required drainage); persistent hematuria n=1; pseudoaneurism n=6).Of the six pericardial effusions, three required drainage.There are no other non-serious ae¿s events or device malfunctions reported in the publication.Suspected device is thermocool /thermocool sf model and catalog number is not available.The concomitant products: 8-f acunav¿ ultrasound catheter.Other non-bwi were used in this clinical trial intracardiac echocardiography (ice) [ a 9-f ultra ice¿ catheter (boston scientific, (b)(4)); irrigated 4-mm tip ablation catheter (chilli ii (boston scientific, (b)(4));sl1 sheath (st.Jude medical, (b)(4)) and agilis¿ steerable introducer sheath (st.Jude medical, (b)(4)).".

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: SIMILAR DEVICE D131801, PMA # P030031/S034
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4150474
• MDR Text Key: 4766842
• Report Number: 9673241-2014-00407
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1318-00
• Device Catalogue Number: D131800
• Device Lot Number: UNKNOWN_D-1318-00-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR