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 Paralysis (1997)

Event Date 12/31/2014

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.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2019-03701, 2029046-2019-03702, 2029046-2019-03703 are related to the same incident.Patient code ¿paralysis¿ was added to reflect phrenic nerve injury/diaphragmatic paralysis.(b)(4).

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was also reported that 1 patient underwent catheter ablation of ventricular tachycardia and suffered phrenic nerve injury.Intervention was not reported.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 navistar thermocol other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: chilli (boston scientific) publication details title: performance of prognostic heart failure models in patients with nonischemic cardiomyopathy undergoing ventricular tachycardia ablation.Objective: this study sought to assess the performance of established risk models in predicting outcomes after catheter ablation (ca) in patients with nonischemic dilated cardiomyopathy (nidcm) and ventricular tachycardia (vt).Methods: the study compared the performance of 8 prognostic scores for the endpoints of death/cardiac transplantation and vt recurrence in 282 consecutive patients ((b)(6)) with nidcm undergoing ca of vt between (b)(6) 1999 and (b)(6) 2014.Discrimination and calibration of each model were evaluated through area under the curve (auc) of receiver-operating characteristic curve and goodness-of-fit test.

• 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: 9129843
• MDR Text Key: 165081055
• Report Number: 2029046-2019-03703
• Device Sequence Number: 1
• Product Code: LPB
• 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: Physician
• Type of Report: Initial
• Report Date: 09/05/2019

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_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/27/2019
• 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