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	12/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr stuck with the wire.The target lesion was located in the left anterior tibial artery.A 1.75mm peripheral rotalink plus was used together with a rotawire.During procedure, it was noted that the burr was stuck with the wire.The procedure was completed with a new 1.75mm burr and wire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned complaint device consisted of a peripheral rotablator plus device.The burr catheter was received attached to the advancer unit along with the rotawire in the device.The rotawire was removed with little restriction due to wire kinks.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically exanimated.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.As the rotawire that was used during the procedure was kinked; functional testing was performed using a test.009 rotawire.The test rotawire was inserted 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.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
Event or Problem Description
It was reported that the burr stuck with the wire.The target lesion was located in the left anterior tibial artery.A 1.75mm peripheral rotalink plus was used together with a rotawire.During procedure, it was noted that the burr was stuck with the wire.The procedure was completed with a new 1.75mm burr and wire.No patient complications were 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: 9468851
• Report Number: 2134265-2019-15689
• Device Sequence Number: 2947804
• Product Code: MCW
• UDI-Device Identifier: 08714729838913
• UDI-Public: 08714729838913
• 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): 01/24/2020

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: 08/27/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024340925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1