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

Model Number	29710
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotaburr became stuck in the rotawire.The target lesion was located in the anterior tibial vessel.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that both device became stuck together inside the patient's body.The procedure was completed with angioplasty.No negative sequelae occurred and no patient complications were reported.
Event or Problem Description
It was reported that the rotaburr became stuck in the rotawire.The target lesion was located in the anterior tibial vessel.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that both device became stuck together inside the patient's body.The procedure was completed with angioplasty.No negative sequelae occurred and no patient complications were reported.It was further reported that the target lesion was 90% stenosed and severely tortuous with a 90 degree turn into the anterior tibial artery.Dynaglide was not used to advance the device.The devices were removed as a unit and the physician had to rewire the vessel.The devices could not be separated from each other once outside the body.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the device has numerous body kinks in the device.The spring tip was inspected, and it was found stretched.Functional test revealed that the wire was able to be removed from the rotablator device with no issues.Dimensional inspection revealed that the components were within specification.
Event or Problem Description
It was reported that the rotaburr became stuck in the rotawire.The target lesion was located in the anterior tibial vessel.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that both device became stuck together inside the patient's body.The procedure was completed with angioplasty.No negative sequelae occurred and no patient complications were reported.It was further reported that the target lesion was 90% stenosed and severely tortuous with a 90 degree turn into the anterior tibial artery.Dynaglide was not used to advance the device.The devices were removed as a unit and the physician had to rewire the vessel.The devices could not be separated from each other once outside the body.

• 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: 10985493
• Report Number: 2134265-2020-17228
• Device Sequence Number: 16968955
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: 08714729863649
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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: 03/30/2022
• Device Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0025424853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 02/03/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/16/2020; 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1