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

Model Number	3243
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
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 shaft leak occurred.A 1.50mm rotapro was selected for use.During preparation, outside the patient, a leak was noted in the middle of the catheter tube.The procedure was completed using an alternative device.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.
Event or Problem Description
It was reported that shaft leak occurred.A 1.50mm rotapro was selected for use.During preparation, outside the patient, a leak was noted in the middle of the catheter tube.The procedure was completed using an alternative device.No patient complications were reported.It was further reported that a tear or hole in the sheath was confirmed.The lot number and event date remains unknown.

• 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: 21048163
• Report Number: 2124215-2024-82628
• Device Sequence Number: 8372758
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 01/30/2025

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 Model Number: 3243
• Device Catalogue Number: 3243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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