MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Thrombosis (2100)

Event Date 01/31/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's report numbers: 2029046-2020-01339, 2029046-2020-01340, 2029046-2020-01342, 2029046-2020-01343, 2029046-2020-01344, 2029046-2020-01345, 2029046-2020-01346, 2029046-2020-01347, 2029046-2020-01348, 2029046-2020-01349, and 2029046-2020-01350.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent catheter ablation of ventricular tachycardias and suffered subclavian vein thrombosis not requiring intervention.I model and catalog number are not available, but the suspected device is unk_navistar thermocool.Other biosense webster devices that were also used in this study: carto-3.Non-biosense webster devices that were also used in this study: agilis sheath, ensite velocity navigation system, abbott cool flextm ablation catheter.Publication details: title: predictors of long-term mortality after catheter ablation of ventricular tachycardia in a contemporary cohort of patients with structural heart disease.Objective: ablation of ventricular tachycardias (vts) in patients with structural heart disease has been established in the past decades as an effective and safe treatment.However, the prognosis and long-term outcome remains poor.Methods: we investigated 309 patients with ischaemic cardiomyopathy (icm) and non-ischaemic cardiomyopathy (nicm) (186 icm, 123 nicm; 271 males; mean age 64.1 ± 12 years; ejection fraction 34 ± 13%) after >_1 vt ablations over a mean follow-up period of 34 ± 28 months.Electrical storm was the indication for 224 patients (73%), whereas 86 patients (28%) underwent epicardial as well as endocardial ablation.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: UNK
• 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 ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10610177
• MDR Text Key: 209392295
• Report Number: 2029046-2020-01341
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 09/08/2020
• 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): Life Threatening
• Patient Age: 64 YR