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); Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr tip separated.A 2.00mm rotapro was selected for use an atherectomy procedure.During preparation, the rotapro advancer connected to the console.When the rotation start button was mistakenly pressed, the burr tip got separated and the stall indicator displayed on the console.The procedure was completed successfully with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the burr tip separated.A 2.00mm rotapro was selected for use an atherectomy procedure.During preparation, the rotapro advancer connected to the console.When the rotation start button was mistakenly pressed, the burr tip got separated and the stall indicator displayed on the console.The procedure was completed successfully with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a rotapro device.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil was stretched and kinked 1.5cm from the burr tip.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to the melted ultem.A melted ultem is due to the interruption of saline, by insufficient flow of saline used during the preparation or during the procedure of the device.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 9553370
• Report Number: 2134265-2019-16363
• Device Sequence Number: 13943156
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 07/14/2021
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0024108651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/25/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1