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

Model Number	H749394672000
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.(b)(6).E1.(b)(6).
Event or Problem Description
It was reported that the burr was stuck with the rotawire.A 2.00mm rotapro and rotawire drive were selected for use.During removal, the burr got stuck with the rotawire.The burr and wire were removed as one unit from the patient's body.The procedure was completed.There was no patient complications reported post procedure.
Event or Problem Description
It was reported that the burr was stuck with the rotawire.A 2.00mm rotapro and rotawire drive were selected for use.During removal, the burr got stuck with the rotawire.The burr and wire were removed as one unit from the patient's body.The procedure was completed.There was no patient complications reported post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device did not identify any damages or defects.During wire insertion test, analysis was performed using the returned rotawire.The returned wire was removed with resistance present due to kinks present on the wire.The burr catheter was not stuck and was able to be removed.Reinsertion of the wire failed as there was resistance due to kink damage present to the wire.No other issues were identified during the product analysis.E1.Initial reporter facility name: (b)(6) hospital.E1.Initial reporter address 1: (b)(6).

• 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: 22159697
• Report Number: 2124215-2025-36672
• Device Sequence Number: 8907067
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)260619(10)35253955
• 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): 10/29/2025

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: 06/19/2026
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0035253955
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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