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

Model Number	3243
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.A 1.50mm rotapro was selected for use.During the procedure, it was noted that the plastic cover of the rotapro shaft was broken.The rotapro was successfully removed from the patient together with the guidewire.The procedure was completed with another rotapro.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
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 damaged at 21cm distal of the burr housing strain relief.The damage was inspected and found to be most evident of pinching.Product analysis confirmed the reported event, as the sheath was torn.
Event or Problem Description
It was reported that a device fracture occurred.A 1.50mm rotapro was selected for use.During the procedure, it was noted that the plastic cover of the rotapro shaft was broken.The rotapro was successfully removed from the patient together with the guidewire.The procedure was completed with another rotapro.There were no patient complications reported post procedure.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17795126
• Report Number: 2124215-2023-51796
• Device Sequence Number: 14000543
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/28/2023

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: 03/06/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031180305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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