MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; SIMILAR DEVICE DI7TCBLRT, PMA # P030031

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Pseudoaneurysm (2605)

Event Date 03/31/2015

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.Other company¿s device that used in this study: 8-mm tip fantasista ablation catheter ((b)(6) lifeline) manufacturer's ref.No: (b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient with non-paroxysmal atrial fibrillation underwent radiofrequency ablation and suffered femoral pseudoaneurysm.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: ¿very long-term clinical outcomes after radiofrequency catheter ablation for atrial fibrillation: a large single-center experience.¿ the purpose of this study was to investigate the very long-term outcomes after radiofrequency catheter ablation for atrial fibrillation in a large number of consecutive patients.The study was conducted from february 2004 and march 2015.Suspected device is navistar ablation catheter, however catalog and lot number are unknown.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: SIMILAR DEVICE DI7TCBLRT, 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: gabriel alfageme ; 33 technology drive; irvine 92618 ; 949789-868
• MDR Report Key: 7284045
• MDR Text Key: 100510661
• Report Number: 2029046-2018-01202
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/23/2018
• 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): Other
• Patient Age: 64 YR