MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; SIMILAR DEVICE NR7TCSIY, PMA # P030031

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient with atrial fibrillation underwent radiofrequency ablation and suffered cardiac tamponade as well as a perforation at the left atrium roof caused by an radiofrequency current induced steam pop.Based on the facts of the case and the author¿s assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: "complications in catheter ablation of atrial fibrillation in 3,000 consecutive procedures balloon versus radiofrequency current ablation" the purpose of this study was to identify predictors of cardiac tamponade during atrial fibrillation ablation using different technologies and strategies.The study was conducted from may 2010 to july 2015.Ablation were performed using an irrigated 3.5- or 4-mm-tip catheter (thermocool navistar, thermocool surround flow, thermocool smarttouch (biosense webster); alcath flux g extra (biotronik)).Multiple attempts have been made to obtain clarification on which device was used during this procedure.However, no further information has been made available.Bwi takes conservative approach to report all the events occurred under navistar thermocool, however catalog and lot number is unknown.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: SIMILAR DEVICE NR7TCSIY, PMA # P030031
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7244098
• MDR Text Key: 99133019
• Report Number: 2029046-2018-01143
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 67 YR