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

Model Number	3243
Medical Device Problem Codes	Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It reported that there was unstable speed.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) arteries.A 2.15mm rotapro was selected for use an percutaneous coronary intervention (pci) procedure of the lad arteries.During the procedure, the device had an abnormal sound and the rotation speed was unstable.The procedure was successfully completed with another device and there were no patient complications 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: 10546767
• Report Number: 2134265-2020-12850
• Device Sequence Number: 14236717
• Product Code: MCX
• UDI-Device Identifier: 08714729893394
• UDI-Public: 08714729893394
• 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
• Report Date (Section B): 09/17/2020

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: 07/22/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025754572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1