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

Model Number	39467-150
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: as the event date was not reported, the first day in the month of the aware date is provided.
Event or Problem Description
It was reported that material damage occurred.A 1.50mm rotapro was selected for rotablation.During procedure, the cover of the wire started melting or being damaged because of the rotations of the wire.The device was removed from the patient in one piece.The procedure was completed successfully, and no patient complications were reported.
Additional Manufacturer Narrative
B3: as the event date was not reported, the first day in the month of the aware date is provided.Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device with a rotawire within the device.Visual inspection of the device found that at 20.6cm distal from the strain relief, the sheath was torn (separated) and the coil was stretched.There were numerous kinks to the sheath and blood was present within the sheath upon device return.The rotawire returned with the device was frozen due to the stretched coil.The proximal end of the rotawire was kinked at the exit of the advancer.Microscope inspection revealed that the coil was stretched for majority of the proximal length up to the separated sheath.The coil was found detached at the same location as the torn sheath.Product analysis confirmed the reported event as the sheath was torn.
Event or Problem Description
It was reported that material damage occurred.A 1.50mm rotapro was selected for rotablation.During procedure, the cover of the wire started melting or being damaged because of the rotations of the wire.The device was removed from the patient in one piece.The procedure was completed successfully, and no patient complications were reported.The device is returning.

• 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: 20333910
• Report Number: 2124215-2024-60904
• Device Sequence Number: 9592694
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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): 11/18/2024

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: 04/24/2026
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0033892162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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