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

Model Number	3256
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console screen flickered then faded to black.A rotapro console was selected for use.During start up and during the procedure, the console screen flickered and faded to black.The procedure was completed with a 1.5 burr.The patient's status was okay post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the console was returned in over all good physical condition.The console was powered up.After 15 minutes, the screen started to flicker.After 1 plus hours, the screen went blank resulting in a white display.The printed circuit assembly (pca) main board had failed.The pca is part of the front housing assembly.
Event or Problem Description
It was reported that the console screen flickered then faded to black.A rotapro console was selected for use.During start up and during the procedure, the console screen flickered and faded to black.The procedure was completed with a 1.5 burr.The patient's status was okay post procedure.

• 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: 12443264
• Report Number: 2134265-2021-11366
• Device Sequence Number: 14665961
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/12/2021

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: RP000934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1