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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the burr was stuck on wire.The target lesion was located in anterior tibial artery.A rotawire and 1.25mm peripheral rotalink plus were selected for use.During the procedure, it was noted that the rotablator did not advance to the longer segment of the anterior tibial artery.The proximal section was successfully treated.When the device was removed, the burr would not pull back on the wire as it was stuck on the wire.The physician attempted to cut the catheter off the wire, however it could not come off.The device was removed as a unit and lost access as a result.Atherectomy of lower extremities was successful though it could not advance further.A balloon was put down and the artery was ballooned.No patient complications were reported and the patient was okay.

• 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: 8599600
• Report Number: 2134265-2019-05042
• Device Sequence Number: 13998287
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/10/2019

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: 02/10/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023330108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1