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 Problems Fistula (1862); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Pseudoaneurysm (2605)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Article title: enhanced efficiency of a novel porous tip irrigated rf ablation catheter for pulmonary vein isolation per a report in the journal of j cardiovasc electrophysiol 2013;24:1328-1335.A prospective randomized study was conducted on 160 patients, by (b)(6) of (b)(6) to compare the efficiency and the safety of 2 different open irrigated tip rf ablation catheters.Mean follow-up time: 20.5 ±7.5 months.From the report there were 4 serious adverse events: 1 patient in the sf group had a tia 2 days after ablation, 1 patient in the thermocool group developed cardiac tamponade requiring urgent thoracotomy.Two (2) patients in the sf group developed femoral puncture-related complications (arterio-venous fistula or pseudoaneurysm) requiring surgery.Per the article, other non-serious ae¿s were also reported: 2 patients in the sf group (arterio-venous fistula or pseudoaneurysm) and 3 in the thermocool group (arterio-venous fistula) developed femoral puncture-related complications and were all treated conservatively.These events are not known to have required extended hospitalization stay.If additional information is received, we will update information in a supplemental report.There are no death events and no device malfunctions reported in the publication.Model and catalog number are not available, but the suspected device are the thermocool sf and the navistar thermocool.This report covers the serious injuries reported with thermocool sf: 1 tia 2 days after ablation, 2 femoral puncture-related complications (arterio-venous fistula or pseudoaneurysm) requiring surgery.

Manufacturer Narrative

(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: 4146531
• MDR Text Key: 4772121
• Report Number: 9673241-2014-00398
• Device Sequence Number: 1
• Product Code: OAE
• 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: 09/17/2014

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-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
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/07/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR