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	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr stuck with the wire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified first right posterolateral segment.A 2.00mm rotapro and rotawire were selected for use.During the procedure, upon withdrawal, it was noted that the burr stuck with the wire.The device was removed as one unit, and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found that the sheath was kinked at the most proximal end of the device.Microscope inspection of the device found no damage or irregularity.Analysis was performed using the returned rotawire.During testing, the returned wire was removed with resistance present.The burr catheter was not stuck and was able to be removed.Reinsertion of the wire failed as there was resistance due to kinks present to the wire.
Event or Problem Description
It was reported that the burr stuck with the wire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified first right posterolateral segment.A 2.00mm rotapro and rotawire were selected for use.During the procedure, upon withdrawal, it was noted that the burr stuck with the wire.The device was removed as one unit, and the procedure was completed.No patient complications were reported.

• 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: 20903442
• Report Number: 2124215-2024-75576
• Device Sequence Number: 5006068
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: 08714729999591
• 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): 01/13/2025

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: 08/07/2026
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0034587587
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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