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	05/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the rotawire.The target lesion was located in posterior tibial vessel.A 2.00mm peripheral rotalink plus and perpiheral rotawire were selected for an atherectomy procedure.The device was used in the upper portion of the posterior tibial vessel.Then, the device was advanced to the mid posterior tibial vessel and became entrapped on the wire while when rotation was occurring.Since the device was unable to be advanced or removed from the wire, the rotalink and rotawire were removed together as a unit.No further atherectomy was completed and the procedure was completed with ballooning.No patient complications were reported and patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined and noted that the coil was stretched.Functional testing was done with a test rotawire and observed no resistance when the rotawire was inserted through the burr and advanced through the entire length of the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr became stuck with the rotawire.The target lesion was located in posterior tibial vessel.A 2.00mm peripheral rotalink plus and perpiheral rotawire were selected for an atherectomy procedure.The device was used in the upper portion of the posterior tibial vessel.Then, the device was advanced to the mid posterior tibial vessel and became entrapped on the wire while when rotation was occurring.Since the device was unable to be advanced or removed from the wire, the rotalink and rotawire were removed together as a unit.No further atherectomy was completed and the procedure was completed with ballooning.No patient complications were reported and patient was fine.

• 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: 8663544
• Report Number: 2134265-2019-06197
• Device Sequence Number: 2182868
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• 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): 06/17/2019

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: 03/24/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023534979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1