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

Model Number	H749394672000
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was stuck in lesion.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.A 2.00mm rotapro was selected for use.During the procedure, the rotation speed was set at 210,000rpm.Dynaglide mode was used while advancing the burr to the lesion.Then, it was noted that the rotaburr stalled and was stuck in the lesion.The device was unstuck by crossing the wire through the lumen and use intravascular lithotripsy (ivl) to break the calcification and release.The procedure was completed with a different device.No further patient complications reported.
Event or Problem Description
It was reported that the burr was stuck in lesion.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.A 2.00mm rotapro was selected for use.During the procedure, the rotation speed was set at 210,000rpm.Dynaglide mode was used while advancing the burr to the lesion.Then, it was noted that the rotaburr stalled and was stuck in the lesion.The device was unstuck by crossing the wire through the lumen and use intravascular lithotripsy (ivl) to break the calcification and release.The procedure was completed with a different device.No further patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The distal portion of the sheath was not returned.Inspection of the device found that the coil was kinked and stretched, and the coil and sheath were detached at the distal end of the burr housing strain relief.The returned burr catheter could not be tested due to the damages to the coil and sheath.In order to determine the functionality of the advancer, a test burr catheter was used.After the burr catheter was connected to the advancer and the advancer was connected to the rotapro console, the returned advancer was able to reach and maintain optimal rpm with no resistance or issues using returned burr catheter.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22952668
• Report Number: 2124215-2025-59136
• Device Sequence Number: 20964734
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)270617(10)36775898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• 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): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0036775898
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown