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

Model Number	3243
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr stuck in the lesion.Vascular access was obtained via the right femoral artery.The 50% stenosed, 3.5mm diameter, target lesion was located in the mildly tortuous and heavily calcified distal left main (lm) to mid left anterior descending artery (lad).A 1.5mm rotapro was selected for use.However, during the procedure, it was noted the burr was stuck in the distal lm.Another wire was placed in the vessel parallel to the rotawire to deliver a balloon which was inflated to free the stuck burr.There were no complications reported, and the patient was stable.

• 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 SCIMED, INC; 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: 21683988
• Report Number: 2124215-2025-17732
• Device Sequence Number: 9308154
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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
• Report Date (Section B): 03/24/2025

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: 06/20/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031861211
• 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: 03/13/2025
• Initial Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 06/21/2023
• 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: Female