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 Problems Hematoma (1884); Not Applicable (3189)

Event Date 01/31/2007

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

It was reported that two patients with symptomatic, drug-refractory persistent atrial fibrillation underwent radiofrequency current (rfc)-based ablation and suffered groin hematoma required blood transfusion or surgical intervention.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: ¿insights into ablation of persistent atrial fibrillation: lessons from 6-year clinical outcomes.¿ the purpose of this study was to explore original phase/frequency mapping methods to locate rotors and track changes induced by their ablation.The study was conducted between august 2003 and january 2007.Suspected device is navistar thermocool ablation catheter, however catalog and lot number are unknown.

Manufacturer Narrative

Additional information was received from author on 03/09/2018.Navistar thermocool d curve catheters were used in this study.Complications occurred between (b)(6) 2003 to (b)(6) 2008.Physician¿s opinion regarding the causality of adverse event was possible procedure-related and patient condition related.The event did not result in the impairment of a body function or damage to a body structure.Patients were fully recovered.Manufacturer's ref.No: (b)(4).

• 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
• MDR Report Key: 7284030
• MDR Text Key: 100510280
• Report Number: 2029046-2018-01208
• 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
• Type of Report: Initial,Followup
• 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
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR