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	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire became stuck in the device.A stenosed target lesion was located at posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use over a rotawire.During the procedure, it was noted that the wire became stuck in the device.Another of the same rotalink device and a new wire to complete the procedure.There was no patient complications reported.
Event or Problem Description
It was reported that the wire became stuck in the device.A stenosed target lesion was located at posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use over a rotawire.During the procedure, it was noted that the wire became stuck in the device.Another of the same rotalink device and a new wire to complete the procedure.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a rotablator plus burr catheter.The advancer and handshake connection were microscopically and visually examined.The burr catheter was detached from the advancer revealing that the handshake connection was not visible and would not retract, the housing was opened during analysis of the device and the handshake connection was found to be pushed down and lying next to the coil inside of the sheath.The coil is stretched and kinked in the sheath.There is excessive wear in the sheath.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, but would not pass the coil damage.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8269054
• Report Number: 2134265-2019-00251
• Device Sequence Number: 2288457
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/19/2019

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: 09/18/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022674133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1