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 Insufficient Information (3190)

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This is a retrospective single-center study.A total of 107 pvi procedures in 71 patients with paroxysmal (32%), persistent (38%) and long standing persistent (30%) atrial fibrillation (af) were analyzed.The aim of the study was to evaluate a single catheter magnetic navigation system (mns) approach in terms of safety and efficacy over long-term.From the report : 1 patient had groin hematomas, which did not prolong the stay in hospital.1 patient had transient ischemic attack.Radiofrequency (rf) current was delivered with a 3.5-mm open-irrigated catheter with power settings of 30w, temperature limit 45 °c, 25¿30 s, step size 3 mm model and catalog number of ablation catheters are not available.Also non bwi products were used during the procedure: 1 decapolar steerable diagnostic catheter was positioned in the coronary sinus (6fr, dynamic deca, c.R.Bard, inc., (b)(4), usa).Fluoroscopic imaging was performed in all patients using a digital imaging system (artis, siemens, inc., (b)(4), usa).Fluoroscopically guided transseptal puncture was performed to position one sheath within the left atrium (sro, 8.5fr and brk¿ transseptal needle, st.Judemedical, inc., (b)(4), usa).

Manufacturer Narrative

The product is not available; therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

• 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: 4037314
• MDR Text Key: 4846387
• Report Number: 2029046-2014-00279
• 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: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

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: NAVISTAR THERMOCOOL
• Device Catalogue Number: NAVISTAR THERMO TC
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/26/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 57 YR