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 12/31/2015

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 lot number was provided by the customer.Concomitant products that used in this study: non-biosense webster devices that were also used in this study: none manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2018-02362; 2029046-2018-02363; 2029046-2018-02364.Are related to the same incident.(b)(4).

Event Description

This complaint is from a literature source.The following complications were reported in this publication: 1 patient with arrhythmogenic right ventricular cardiomyopathy underwent catheter ablation of ventricular tachycardia and suffered pseudoaneurysm requiring prolonged mechanical compression.No further details were provided.Per response from the physician the event was not related to biosense webster's products.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.Non-biosense webster devices that were also used in this study: none.Publication details: title: heterogeneous distribution of substrates between the endocardium and epicardium promotes ventricular fibrillation in arrhythmogenic right ventricular dysplasia/cardiomyopathy.Objective: to investigate the prognostic value of scar distribution in patients with arrhythmogenic right ventricular cardiomyopathy (arvc).Methods: between 2008 and 2015, 80 consecutive arvc patients underwent an electrophysiological study with ablation.Thirty-four patients receive both endocardial and epicardial mapping.Abnormal endocardial substrates and epicardial substrates were characterized.".

• 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: 8126344
• MDR Text Key: 129152758
• Report Number: 2029046-2018-02364
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/03/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 47 YR