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	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rota burr was stuck with the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm rotapro and rotawire were selected for use.During the procedure, upon removal, the rota burr got stuck with the rotawire.Both devices were removed together as one unit.The procedure was completed with another of the same device.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.Analysis was performed using the returned rotawire.During testing, the returned wire was able to be removed with resistance but was not able to be reinserted due to a kink in the wire.In order to confirm the functionality of the rotapro device, further functional testing was completed with a test rotawire.The wire was able to be inserted into the burr and advanced through the advancer with no resistance or issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the rota burr was stuck with the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm rotapro and rotawire were selected for use.During the procedure, upon removal, the rota burr got stuck with the rotawire.Both devices were removed together as one unit.The procedure was completed with another of the same device.There was no patient complications reported post procedure.

• 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: 21277625
• Report Number: 2124215-2025-04454
• Device Sequence Number: 21170960
• 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): 03/17/2025

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: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0035190212
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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