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

Model Number	M00440000
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: 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.(b)(4).
Event or Problem Description
It was reported that the remote control would not stop ablation.During an ablation procedure, a maestro 4000¿ remote control was selected for use.During the procedure, the remote control would not stop ablation.The remote had to be turned off to resolve the issue.The procedure was completed and no patient complications occurred.

• Brand Name: MAESTRO 4000¿ CONTROLLER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): STELLARTECH RESEARCH CORPORATION; 1346 bordeaux drive; sunnyvale CA 94089
• MDR Report Key: 7619865
• Report Number: 2134265-2018-05739
• Device Sequence Number: 1397263
• Product Code: OAD
• UDI-Device Identifier: 08714729862062
• UDI-Public: 08714729862062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00440000
• Device Catalogue Number: 4000
• Device Lot Number: 0503170170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR