MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; SIMILAR DEVICE NI75TCJH, PMA # P030031

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Cardiogenic Shock (2262)

Event Date 10/31/2011

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.(b)(4).

Event Description

This complaint is from a literature source.It was reported that 9 patients in the rescue plvad group underwent ventricular tachycardia (vt) ablation for recurrent, drug refractory vt and suffered from cardiogenic shock as manifested by hypotension and/or pulmonary edema.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: ¿outcomes of pre-emptive and rescue use of percutaneous left ventricular assist device in patients with structural heart disease undergoing catheter ablation of ventricular tachycardia¿ the purpose of this study was to assess the outcomes of pre-emptive and rescue use of plvad during vt ablation in patients with ischemic and non-ischemic cardiomyopathy.The study was conducted between january 2009 and october 2011.Suspect device is an externally irrigated 3.5 mm navistar thermocool ablation catheter, however catalog and lot numbers are unknown.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: SIMILAR DEVICE NI75TCJH, 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, CA 92618 ; 949789-868
• MDR Report Key: 7299740
• MDR Text Key: 101057399
• Report Number: 2029046-2018-01244
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• 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: 01/29/2018
• 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
• Patient Age: 69 YR