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	03/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on the wire.The target lesion area was located in the left posterior tibial artery.A 2.00mm peripheral rotalink plus was selected for use together with a rotawire.During the procedure, it was noted that the burr was stuck on the wire.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.The returned product consisted of a peripheral rotablator plus device.The advancer unit and burr catheter were received together.The returned rotawire was received in the device.The rotawire was able to be removed from the device with no issue.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically examined.There are numerous sheath kinks.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 is stretched.Functional testing was performed using the returned 009 rotawire.After the rotawire was removed from the device with no issue or resistance the rotawire was reinserted through the burr and advanced through the entire length of the device with no resistance.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr was stuck on the wire.The target lesion area was located in the left posterior tibial artery.A 2.00mm peripheral rotalink plus was selected for use together with a rotawire.During the procedure, it was noted that the burr was stuck on the wire.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine 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: 9957639
• Report Number: 2134265-2020-05007
• Device Sequence Number: 2596721
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• 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): 05/15/2020

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: 11/10/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024747390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1