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

Model Number	H749395141500
Medical Device Problem Codes	Device-Device Incompatibility (2919); Output below Specifications (3004); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the burr became stuck.The 95% stenosed target lesion was located in the mildly tortuous and moderately superficial femoral artery (sfa).A 1.50 mm peripheral rotapro burr-advancer, set at a rotation speed of 170,000 rpm, was selected for treatment of the diseased area located within an existing stent.The burr was advanced to the lesion, reaching speeds of 165,000 -168,000 rpm, and became caught in the stent struts resulting in a stall.After several minutes of manipulating the device, the burr broke free of the stent and was removed in dynglide mode via the rotawire.Intervention was continued by advancing a balloon and stent over the rotawire to complete the procedure.The patient fully recovered.During the procedure, upon the first pass at a set speed of 17k rpm, the burr tangled and got caught on the existing stent struts distal sfa.The burr stalled and would not spin.Manipulation of the device release the burr and remove over the wire intact.The procedure was completed with an alternative method.There were no complications reported and patient fully recovered post procedure.

• 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: 23926911
• Report Number: 2124215-2025-93775
• Device Sequence Number: 18476233
• Product Code: MCW
• UDI-Device Identifier: 00191506007126
• UDI-Public: (01)00191506007126(17)270724(10)37049505
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 12/30/2025

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: H749395141500
• Device Catalogue Number: H749395141500
• Device Lot Number: 0037049505
• 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: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 07/24/2025
• 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