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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck in the vessel.A 1.25mm peripheral rotalink plus was selected for use for an atherectomy procedure to treat the pt distal chronic total occlusion (cto) and the common lateral plantar.During advancement to the pt cto the 1.25mm peripheral rotalink plus could not advance to the lesion.The rotalink plus was exchanged for another same size rotalink plus.The second 1.25mm peripheral rotalink plus advanced to the pt cto.During atherectomy of the common lateral and 1.25mm peripheral rotalink plus got momentarily stuck in the vessel.Consequently, the physician administered nitroglycerin to aid in the removal of the 1.25mm peripheral rotalink plus.All the devices were removed intact and the procedure was completed.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: 11558747
• Report Number: 2134265-2021-03493
• Device Sequence Number: 11501869
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026378248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention