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

Model Number	39467-175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak has occurred.The stenosed target lesion was located in the severely calcified artery.A 1.75mm rotapro was selected for use.During the procedure, it was noted that the shaft was leaking saline.The procedure was completed with another of the same device.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Inspection of the device did not identify any damages or defects.As the advancer used in the procedure was not returned, a test advancer was used during analysis.When the test advancer was connected to the returned burr catheter and liquid infusion was performed, a steady drip of fluid noted from the distal end of the sheath as intended by design.No abnormal leaks were noted from the sheath or advancer.
Event or Problem Description
It was reported that a leak has occurred.The stenosed target lesion was located in the severely calcified artery.A 1.75mm rotapro was selected for use.During the procedure, it was noted that the shaft was leaking saline.The procedure was completed with another of the same device.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: 20495869
• Report Number: 2124215-2024-64881
• Device Sequence Number: 17032715
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 01/17/2025
• Device Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0030872317
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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