MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 3000 CARDIAC ABLATION SYSTEM - CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86245

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported a maestro 3000 cardiac ablation system was selected for use.Equipment presents a lot of interference in the intracavitary signals of the therapeutic catheter, even placing grounding may be a problem of current leakage and this interference worsens with the application of radio frequency (rf) ablation.In addition, the power drops when rf is applied, the power does not increase and not able to reach the programmed power output.It is unknown if this led to incomplete or inadequate ablation.No further patient or procedure information was provided.

• Brand Name: MAESTRO 3000 CARDIAC ABLATION SYSTEM - CONTROLLER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15590381
• MDR Text Key: 302067547
• Report Number: 2124215-2022-41144
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86245
• Device Catalogue Number: 86245
• Device Lot Number: 021313004M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1