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

Model Number	3243
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.Vascular access was obtained via the radial artery.A 1.50mm rotapro and a rotapro console were selected for use.During the test period outside the patient, the rotapro advancer was connected to the rotapro console, but the advancer button failed to activate and start the rotation.The rotapro was stuck because of the burr.Consequently, a stall message was displayed on the rotapro console.A new 1.50mm rotapro advancer was then used, but the same issue was encountered.The procedure was not completed and was continued a day later with the same console with no issue.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The advancer, drive shaft, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device did not identify any damages or defects.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch (ablation button) was pressed, the device stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled and the interior components were inspected for damages or defects.During destructive testing, it was identified that the turbine was corroded, indicating the presence of dried saline within the device.It was considered likely that the presence of dried saline interfered with the devices ability to rotate, leading to a device stall.
Event or Problem Description
It was reported that the procedure was cancelled.Vascular access was obtained via the radial artery.A 1.50mm rotapro and a rotapro console were selected for use.During the test period outside the patient, the rotapro advancer was connected to the rotapro console, but the advancer button failed to activate and start the rotation.The rotapro was stuck because of the burr.Consequently, a stall message was displayed on the rotapro console.A new 1.50mm rotapro advancer was then used, but the same issue was encountered.The procedure was not completed and was continued a day later with the same console with no issue.There were no patient complications.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17279009
• Report Number: 2124215-2023-32949
• Device Sequence Number: 3554984
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 11/06/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0030490441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown