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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer unit and burr catheter were received together.The detached burr and wire were not received for analysis.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.There are numerous sheath kinks.The coil is stretched and broken 135.7cm from the strain relief.There are fibers (fm) wrapped around the coil.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr disconnected from the shaft.The target lesion was located in the left tibial-peroneal trunk.A 1.75mm peripheral rotalink plus was selected for use.During procedure, it was noted that the burr disconnected from the drive shaft.Consequently, the burr was pulled out with the wire and then the vessel was re-wired and ballooned with an angioplasty balloon.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: 8451737
• Report Number: 2134265-2019-02979
• Device Sequence Number: 19580481
• 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
• Report Date (Section B): 03/26/2019

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: 11/05/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022895500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR