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

Model Number 86338

Device Problem Device Remains Activated (1525)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that there was a failure to halt radiofrequency (rf) ablation delivery.During an ablation procedure, while ablating with the foot pedal, energization continued even when the foot pedal was removed.Energization was stopped via an off switch on the main unit.There were no reported patient issues and the patient outcome was "good.".

• Brand Name: MAESTRO 4000 CONTROLLER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9203586
• MDR Text Key: 165328481
• Report Number: 2134265-2019-12636
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729861935
• UDI-Public: 08714729861935
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86338
• Device Catalogue Number: 86338
• Device Lot Number: 0404170425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1