MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3243
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the wire.A 2.00mm rotapro and rotawire were selected for use in an atherectomy procedure in severely calcified lesion.The rotapro was prepped and platformed at 180,000 rpm outside the patient, then advanced over the wire.During insertion, the burr became stuck on the wire inside the patient.The rotapro and the rotawire were removed together as one unit from the patient.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that the burr became stuck on the wire.A 2.00mm rotapro and rotawire were selected for use in an atherectomy procedure in severely calcified lesion.The rotapro was prepped and platformed at 180,000rpm outside the patient, then advanced over the wire.During insertion, the burr became stuck on the wire inside the patient.The rotapro and the rotawire were removed together as one unit from the patient.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system with the rotawire.The burr catheter was received attached to the advancer unit with the rotawire inside the rotapro device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the rotapro device.The rotawire was received inside the rotapro device, so the wire was attempted to be removed.The rotawire was able to be moved distally out of the burr catheter with no resistance or issues.Hence, the wire was not stuck on the wire.Product analysis did not confirm the reported event, as the rotawire was able to be removed from the rotapro device with no resistance or issues.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11752657
• Report Number: 2134265-2021-05457
• Device Sequence Number: 11561372
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 02/05/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026758933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1