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

Model Number	3243
Medical Device Problem Codes	Output Problem (3005); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.
Event or Problem Description
It was reported that a rupture of the sheath occurred.A 1.75mm rotapro was selected for use.It was noted that there was a rupture of the sheath during use.A drop in rotational speed occurred.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device found that the sheath was torn at 67cm from the burr housing strain relief.Blood was identified within the sheath due to the tear.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 due to the damaged sheath and the blood within the sheath.Product analysis confirmed the reported events, as the sheath was damaged and blood was within the sheath, causing the device to stall during analysis.
Event or Problem Description
It was reported that a rupture of the sheath occurred.A 1.75mm rotapro was selected for use.It was noted that there was a rupture of the sheath during use.A drop in rotational speed occurred.No patient harm resulted in relation to this event.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16599338
• Report Number: 2124215-2023-13760
• Device Sequence Number: 16540011
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 11/13/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0030534628
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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