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

Model Number	3243
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that burr separation occurred.A 1.75mm rotapro was selected for the right coronary artery (rca) procedure.While the physician adjusting the rotation speed to 180,000rpm, the rotapro burr detached outside the patient.The procedure was completed with another rotapro device.There were no complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of the rotapro atherectomy device.The device was received with the burr separated.The burr was not returned for analysis.The advancer, drive shaft, handshake connection, and coil were visually and microscopically examined.Inspection of the device found that the coil had been kinked and stretched at the point of detachment from the burr.Product analysis confirmed the reported event, as the coil was kinked, stretched and broken.
Event or Problem Description
It was reported that burr separation occurred.A 1.75mm rotapro was selected for the right coronary artery (rca) procedure.While the physician adjusting the rotation speed to 180,000rpm, the rotapro burr detached outside the patient.The procedure was completed with another rotapro device.There were no complications reported.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13393367
• Report Number: 2134265-2022-00898
• Device Sequence Number: 14516313
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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 Expiration Date: 08/27/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0027919823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown