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

Model Number	3256
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled/rescheduled post-sedation.A rotapro console was selected for use in an atherectomy procedure.While testing the device outside the body, the rotation speed was inconsistent.There was no evidence of physical damage to the device.The procedure was not completed due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the console was returned with the electrical connector partially chipped.The rest of the console was in over all good physical condition.The unit passed all incoming functional tests.The damaged electrical damage is cosmetic and did not affect functionality.Functional testing was unable to replicate the fault condition.The rotapro console passed calibration and full functional final testing.
Event or Problem Description
It was reported that the procedure was cancelled/rescheduled post-sedation.A rotapro console was selected for use in an atherectomy procedure.While testing the device outside the body, the rotation speed was inconsistent.There was no evidence of physical damage to the device.The procedure was not completed due to this event.No patient complications were reported.

• 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: 10949331
• Report Number: 2134265-2020-16905
• Device Sequence Number: 14282220
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: RP000895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/22/2021
• Patient Sequence Number: 1