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

Model Number D-1197-00

Device Problem Insufficient Information (3190)

Patient Problems Hemothorax (1896); Pseudoaneurysm (2605)

Event Date 04/01/2012

Event Type  Injury  

Event Description

Article title: atrial arrhythmias following surgical af ablation: electrophysiological findings, ablation strategies, and clinical outcome.Per a report in the journal of j cardiovasc electrophysiol.2014 jul;25(7):725-38., a single-center retrospective study was conducted on 82 patients, by huo y of the heart center leipzig in leipzig, germany et al., to supplement the existing scientific evidence by describing electrophysiological findings, arrhythmia mechanisms, catheter ablation strategies, and clinical outcomes of aa following intraoperative afa in a large cohort of patients.The patients were included from (b)(6) 2006 to (b)(6) 2012.Median follow-up time: 18 months.From the report there was 1 serious adverse event: post interventionally, 1 patient developed a hematothorax, which was treated successfully by thorax drainage.Per the article, 2 other non-serious ae¿s were also reported: in 2 patients, an inguinal pseudoaneurysm was found.These events are not known to have required intervention/treatment nor extended hospitalization stay.If additional information is received, we will update information in a supplemental report.There are no death events or device malfunctions reported in the publication.It is unknown if the events occurred with the use of a biosense webster device.Model and catalog number are not available.Of 82 patients, 17 underwent rf ablation and 65 underwent cryo ablation.For some of the rf patients, a navistar thermocool catheter was used, which is therefore considered the suspected device in this report.Concomitant products: carto mapping system was used in some of the procedures.This complaint covers the hematothorax event.

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.Concomitant bwi products: product: carto mapping system, us catalog # unknown, serial # unknown.(b)(4).

• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4135131
• MDR Text Key: 4795587
• Report Number: 2029046-2014-00347
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• 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: 09/02/2014

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: D-1197-00
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 10/02/2014
• 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
• Patient Age: 65 YR