MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	29711
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guidewire.The target lesion was located in the tibioperoneal trunk.A 2.00 mm peripheral rotalink and peripheral rotawire and wireclip torquer were selected for use.During the procedure, it was noted that the device stalled during advancement.About 75% of the rotablation was completed and the device was being withdrawn in dynaglide mode when the burr became stuck on the wire.The physician had difficulty removing it from the patient's body.The rotalink and rotawire were removed together.The rotablation procedure was completed with this device as the majority of the case was completed.There were multiple areas and the last area was where they had the problem.A new wire was advanced and ballooning completed.There were no patient complications and the patient was fine after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The guidewire returned stuck inside the catheter of the burr device and it was not possible to release.The device has the distal tip kinked; besides, the body was kinked in two different sections, approximately at 5cm and 125cm from the proximal end.No more damages were found in the device.Dimensional inspection of the device that could be measured were performed and were within specifications.
Event or Problem Description
It was reported that the burr became stuck on the guidewire.The target lesion was located in the tibioperoneal trunk.A 2.00mm peripheral rotalink and peripheral rotawire and wireclip torquer were selected for use.During the procedure, it was noted that the device stalled during advancement.About 75% of the rotablation was completed and the device was being withdrawn in dynaglide mode when the burr became stuck on the wire.The physician had difficulty removing it from the patient's body.The rotalink and rotawire were removed together.The rotablation procedure was completed with this device as the majority of the case was completed.There were multiple areas and the last area was where they had the problem.A new wire was advanced and ballooning completed.There were no patient complications and the patient was fine after the procedure.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8799133
• Report Number: 2134265-2019-08349
• Device Sequence Number: 343553
• Product Code: MCW
• UDI-Device Identifier: 08714729838890
• UDI-Public: 08714729838890
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 03/25/2021
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0023543393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1