MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) MAESTRO FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004218500
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.Device evaluation observed the strain relief guard over cord in good physical shape.No damage was noted on cord¿s insulation jacket.The pedal presses down evenly with normal clicking sound.Connector to maestro was in good physical shape.Pins were observed to be straight and grounding shield was intact.Using an ohm meter, the foot switch was placed on the floor and activated.The switch turned on and off with no issues.The cord was pulled and flexed along the length and near the connector and pedal¿s strain reliefs and no issues were observed.The foot switch passed all testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that a device deactivation issue occurred.A maestro foot switch failed to deactivate even after use.The console needed to be shut down in order to deactivate the device.There was no patient involved during the event.

• Brand Name: MAESTRO FOOT SWITCH
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 6990672
• Report Number: 2134265-2017-11087
• Device Sequence Number: 684186
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: M004218500
• Device Catalogue Number: 21850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1