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

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr locked on to the wire.The 85% stenosed target lesion area was located in a severely calcified peroneal artery on the leg.A 1.75mm peripheral rotalink plus was selected for use together with a rotawire.During the procedure, it was noted that the burr got stuck on the wire and stopped spinning.The device was completely removed together with the wire.However, they need to regain wire access.The procedure was completed with a different device.No patient complications were reported and the patient's condition was excellent post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer unit.A rotawire was returned in the device.The wire was removed from the device with little issue due to numerous small kinks along the wire.There was blood visible in the drip line.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically exanimated.Microscopic examination of the device revealed that the annulus was damaged and not round which is consistent with damage seen with the use of a rotawire.The coil was stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr locked on to the wire.The 85% stenosed target lesion area was located in a severely calcified peroneal artery on the leg.A 1.75mm peripheral rotalink plus was selected for use together with a rotawire.During the procedure, it was noted that the burr got stuck on the wire and stopped spinning.The device was completely removed together with the wire.However, they need to regain wire access.The procedure was completed with a different device.No patient complications were reported and the patient's condition was excellent post procedure.

• 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: 9595818
• Report Number: 2134265-2020-00128
• Device Sequence Number: 19451265
• Product Code: MCW
• UDI-Device Identifier: 08714729838913
• UDI-Public: 08714729838913
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/21/2020

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: 09/11/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024421606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR