MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86248

Device Problem Output below Specifications (3004)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Additional premarket / 510(k) #'s: p980003, p020025.

Event Description

It was reported that the generator controller exhibited low power.During a procedure a maestro 4000 controller was selected for use.The generator unit was not getting to max temperature and was staying at low power.Multiple catheters were attempted to be used with the equipment, but the issue remained.The controller was replaced with a different model device.The procedure was completed with no patient complications.The controller has been received at boston scientific's post market laboratory where it is awaiting analysis.

Event Description

It was reported that the generator controller exhibited low power.During a procedure a maestro 4000 controller was selected for use.The generator unit was not getting to max temperature and was staying at low power.Multiple catheters were attempted to be used with the equipment, but the issue remained.The controller was replaced with a different model device.The procedure was completed with no patient complications.The controller has been received at boston scientific's post market laboratory where it is awaiting analysis.

Manufacturer Narrative

Additional premarket / 510(k) #'s: p980003, p020025.The maestro 4000 controller was returned and analyzed by the sfmd.The returned device analysis showed no evidence of defect, malfunction or damage upon visual inspection and functional testing.The reported error could not be reproduced, so the reported event was not confirmed.

• Brand Name: MAESTRO 4000 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: 16808518
• MDR Text Key: 313938423
• Report Number: 2124215-2023-15835
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86248
• Device Catalogue Number: 86248
• Device Lot Number: 0206170414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1