MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NAVISTAR THERMOCOOL

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

Patient Problems Bleeding (1738); Thrombosis (2100)

Event Date 06/01/2006

Event Type  Death  

Event Description

The purpose of this prospective multicenter study was to compare results of catheter ablation in patients with paroxysmal atrial fibrillation (paf) and those with nonparoxysmal atrial fibrillation (npaf).Patients were enrolled as follows: 953 patients from (b)(6) usa) from december 2000 to june 2004; 102 patients from (b)(6) usa) from june 2001 to december 2002; 89 patients from (b)(6), from march 2004 to march 2006; and 260 patients from (b)(6) from september 2002 to june 2006.From the report: - 5 patients had tamponade, - 6 patients had thromboembolic events including transient ischemic attack or stroke, - 184 patients had pv stenosis ( of those 18 patients had severe pulmonary vein stenosis; 44 patients (3.1%) had moderate (51%¿70%) pv stenosis; another 122 had mild (31%¿50%) stenosis.- 1 patient had a nonhemorrhagic stroke and underwent an angioplasty.He subsequently had hemorrhagic conversion requiring hemicraniectomy.He later developed acute deep venous thrombosis, which was followed 2 weeks later by a fatal pulmonary embolism (this event is reported under related complaint.) - 5 patients had partial or complete diaphragmatic paralysis.- 2 patients had transient altered mental status.- 1 patient had optic neuritis.- 3 patients had major vascular bleed.- 1 patient had retroperitoneal bleeding.- 1 patient had hemothorax.- 1 patient had deep venous thrombosis.- 1 patient had femoral arteriovenous fistula.- 1 patient had coronary embolism.-1 patient had lasso entrapment in the mitral valve (this event is reported under related complaint.).

Manufacturer Narrative

The product was discarded, therefore, no product failure analysis can be conducted, device malfunction cannot be confirmed 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant product: product name: lasso: us catalog #: unknown, lot #: unknown.Product name: acunav 10fr us catalog #: unknown lot #: unknown non-bwi product was also used: product name: 4-mm internal cooled-tip catheter (ep technologies): catalog and lot #: unknown.Manufacturer's reference # (b)(4), are related to the same event.(b)(4).

Manufacturer Narrative

Literature article and article summary spreadsheet were missing in 3500a initial.This is to correct it with attachments of article and article summary spreadsheet.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 4144536
• MDR Text Key: 4787483
• Report Number: 2029046-2014-00354
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

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: NAVISTAR THERMOCOOL
• 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
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 56 YR