MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	29720
Medical Device Problem Codes	Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the middle superficial femoral artery (sfa).A 2.50mm peripheral rotalink plus was selected for use in an atherectomy procedure.During the atherectomy procedure.It was noted that the rota burr kept stalling, the rpms dropped from 170,000 to 50,000 and then stopped.The device was removed, and it was revealed that there was fibrous tissue on the guidewire.The procedure was cancelled.No patient complications reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10164820
• Report Number: 2134265-2020-08162
• Device Sequence Number: 2400862
• Product Code: MCW
• UDI-Device Identifier: 08714729838968
• UDI-Public: 08714729838968
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 10/03/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024543704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1