MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_CELSIUS THERMOCOOL

Catalog Number UNK_CELSIUS THERMOCOOL

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

Patient Problem Pseudoaneurysm (2605)

Event Date 12/31/2017

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 lot number was provided by the customer.Concomitant products used in this study: carto, thermocool smarttouch, thermocool smarttouch sf.Non-biosense webster devices that were also used in this study: none.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2018-02353; 2029046-2018-02354; 2029046-2018-02355.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: 1 patient underwent catheter ablation of focal ventricular arrhythmia in the setting of cardiomyopathy suffered femoral pseudoaneurism, requiring thrombin injection.No further details were provided.Multiple requests for clarification have been sent to the corresponding author, but no additional details were provided at this time.If additional details will be provided this report will be updated accordingly.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is thermocool.Other biosense webster devices that were also used in this study: carto, thermocool smarttouch, thermocool smarttouch sf.Non-biosense webster devices that were also used in this study: none.Publication details: title: ventricular ectopy in the context of left ventricular systolic dysfunction: risk factors and outcomes following catheter ablation.Objective: to assess medium term outcomes of focal ventricular arrhythmia (va) ablation in the setting of cardiomyopathy (cmp) and to validate published risk factors for ectopy-mediated cardio myopathy (emc).Methods: medium term recovery of left ventricular (lv) function and freedom from va recurrence was assessed and compared between patients undergoing focal va ablation in the setting of cmp (n = 53) and a control group with normal lv function (n = 98) between 2011 and 2017.Total = 152 patients.

• Brand Name: UNK_CELSIUS THERMOCOOL
• Type of Device: UNK_CELSIUS THERMOCOOL
• 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: 8112326
• MDR Text Key: 128729864
• Report Number: 2029046-2018-02352
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CELSIUS THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR