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

Model Number	H749395141250
Medical Device Problem Codes	Device Damaged by Another Device (2915); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured, and manipulation was required to remove it from the body.A 1.25mm peripheral intervention rotapro was selected for use.During procedure for test period, it was noted that the device was severed outside the body but had to be manipulated to remove it from the body.Physician regained wire access with a different wire before exchanging it for a new extra support rotawire.No patient complications were reported and the patient status was good post procedure.
Event or Problem Description
It was reported that the device was fractured, and manipulation was required to remove it from the body.A 1.25mm peripheral intervention rotapro was selected for use.During procedure for test period, it was noted that the device was severed outside the body but had to be manipulated to remove it from the body.Physician regained wire access with a different wire before exchanging it for a new extra support rotawire.No patient complications were reported and the patient status was good post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The burr catheter was received attached to the advancer.Inspection of the device did not identify any damages or defects.After destructive testing was performed, inspection did not identify any damages or defects.Microscope inspection of the device did not identify any damages or defects.After destructive testing was performed, inspection did not identify any damages or defects.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and removed from the device with no resistance or issues.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.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled.Product analysis did not confirm the reported events, as no damages or defects within the device were identified during destructive testing, and clinical circumstances were not able to be replicated.

• Brand Name: PERIPHERAL ROTAPRO
• Common Device Name: CATHETER, PERIPHERAL, 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21313745
• Report Number: 2124215-2025-05247
• Device Sequence Number: 12804225
• Product Code: MCW
• UDI-Device Identifier: 00191506007119
• UDI-Public: 00191506007119
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K220962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Expiration Date: 07/25/2025
• Device Model Number: H749395141250
• Device Catalogue Number: H749395141250
• Device Lot Number: 0032092036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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