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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the burr detached from the catheter.A1.50mm peripheral rotalink plus was selected for use.During preparation, the tip of the burr came off and detached from the catheter.The procedure was completed with a different device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned complaint device consisted of a rotablator plus catheter.The sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed that the coil was separated 145.7cm from the handshake connection.The burr was missing.The coil was stretched, and the sheath was damaged at the distal end.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the tip of the burr detached from the catheter.A1.50mm peripheral rotalink plus was selected for use.During preparation, the tip of the burr came off and detached from the catheter.The procedure was completed with a different device.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: 10087855
• Report Number: 2134265-2020-06946
• Device Sequence Number: 11378871
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 01/16/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0025060663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1