MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3256
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rotation speed was erratic.A rotapro console was selected for an atherectomy procedure.During the procedure, the rotation speed fluctuated and rpms could not be maintained.The procedure was completed with this device.No patient complications were reported, and the patient is in good condition post-procedure.
Event or Problem Description
It was reported that rotation speed was erratic.A rotapro console was selected for an atherectomy procedure.During the procedure, the rotation speed fluctuated and rpms could not be maintained.The procedure was completed with this device.No patient complications were reported, and the patient is in good condition post-procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the rotapro console serial number (b)(6) was returned.The console was returned in overall good physical condition.The unit passed all incoming functional tests.Unable to replicate the fault condition.The rotapro passed calibration and full functional final testing.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10935745
• Report Number: 2134265-2020-16761
• Device Sequence Number: 19495433
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP001588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1