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 Problems Death (1802); Cardiogenic Shock (2262)

Event Date 12/31/2015

Event Type  Death  

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 2 patients with infarct related ventricular tachycardia underwent radiofrequency ablation and died during the index hospitalization due to cardiogenic shock a mean of 11 days postablation.Title: ¿thromboembolic prophylaxis protocol with warfarin after radiofrequency catheter ablation of infarct-related ventricular tachycardia.¿ the purpose of this study was to evaluate a thromboembolic prophylaxis protocol after ventricular tachycardia (vt)ablation.The study was conducted between 2008 and 2015.A 217 patients were enrolled in this study.Thermocool catheters were used in this study, however catalog and lot number were 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: 7394271
• MDR Text Key: 104250652
• Report Number: 2029046-2018-01376
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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: 03/14/2018
• 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): Death
• Patient Age: 68 YR