MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE 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 Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device was unable to halt ablation.A maestro foot switch was used in a trioventricular reentrant tachycardia ablation.However during ablation the physician tried end the ablation using maestro foot switch but ablation did not stop.Ablation was then stopped manually which led to 4sec longer ablation then planned.The procedure was completed with this device.No patient complications were reported.
Event or Problem Description
It was reported that the device was unable to halt ablation.A maestro foot switch was used in a trioventricular reentrant tachycardia ablation.However during ablation the physician tried end the ablation using maestro foot switch but ablation did not stop.Ablation was then stopped manually which led to 4sec longer ablation then planned.The procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Updated: device avail.For eval., returned to mfr.On., device returned to mfr., device evaluated by mfr., eval summary, method codes, results codes, conclusion codes.Device evaluated by manufacturer - the foot guard was in overall good physical condition.The strain relief guard over cord was in good physical shape.No damage was noted to the cord¿s insulation jacket.The pedal presses down evenly with normal clicking sound.The connector to maestro is in good physical shape.Pins are straight and grounding shield is intact.Using an ohm meter the foot switch was placed on the floor and activated.The switch turned on off with no issues.The cord was pulled and flexed along the length and near the connector and pedal¿s strain reliefs.No issues observed.The foot switch passed all electrical and functional testing.When removing the foot pedal¿s cover, the trigger mechanism could move out of place.However, when the cover was put back on, the trigger mechanism moved back to the correct orientation.A service history review was performed on the rf ablation foot switch.There was found nothing to indicate any possible service-related causes for the complaint.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).

• Brand Name: MAESTRO FOOT SWITCH
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• MDR Report Key: 7650660
• Report Number: 2134265-2018-05772
• Device Sequence Number: 11371379
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: M004218500
• Device Catalogue Number: 21850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/30/2018
• Patient Sequence Number: 1