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 Transient Ischemic Attack (2109)

Event Date 05/29/2018

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: 2029046-2019-03402 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 atrial fibrillation and suffered transient ischemic attack without sequelae.No additional 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 navistar thermocool.Other biosense webster devices that were also used in this study: none.Non-biosense webster devices that were also used in this study: none.Publication details: title: comparison of two modes of long-term ecg monitoring to assess the efficacy of catheter ablation for paroxysmal atrial fibrillation.Objective: the purpose of this prospective study was to compare the utility of daily ecg monitoring with episodic card recorder (ecr) vs.Periodic monitoring with episodic loop recorder (elr) for the detection of post-blanking af/at recurrences during early (months 4-6) and late (months 7-12) periods after catheter ablation for paroxysmal af.Methods: the study included 105 consecutive patients, who received ecr for 12 months and were instructed to send at least 2 random ecg recordings daily with extra-recordings during symptoms.The patients were simultaneously monitored for one week with elr at the end of each period (months 6 and 12).Accepted: may 29, 2018.

• 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: 8776401
• MDR Text Key: 150575981
• Report Number: 2029046-2019-03403
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 06/18/2019

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: 06/18/2019
• Initial Date FDA Received: 07/10/2019
• 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: 58 YR