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

Model Number	3243
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign material on the burr tip.A 1.75mm rotapro was selected for use in an atherectomy procedure.During loading of the rotapro onto the guidewire, debris was observed on the tip of the burr.The burr never entered the patient's body.The rotapro was removed and exchanged for another of the same.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of the rotapro atherectomy system.The burr catheter was received detached from the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.The burr was inspected, and no debris was identified on the tip or body of the burr.
Event or Problem Description
It was reported that there was foreign material on the burr tip.A 1.75mm rotapro was selected for use in an atherectomy procedure.During loading of the rotapro onto the guidewire, debris was observed on the tip of the burr.The burr never entered the patient's body.The rotapro was removed and exchanged for another of the same.No patient complications were reported.

• 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: 11844772
• Report Number: 2134265-2021-06451
• Device Sequence Number: 14308946
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 03/19/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0027001417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/20/2021
• Patient Sequence Number: 1