MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; catheter, coronary, atherectomy

Model Number	H749394671250
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr detached requiring additional intervention.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.A 1.25mm rotapro was selected for use.During the procedure, the rotational speed dropped from the set speed of 220,000 rpm and the tip of the burr separated in the lesion site.Snaring was done to remove the fragment.The procedure was completed with a different device.There were no complications 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50085276
• Report Number: 2124215-2026-40911
• Device Sequence Number: 21332608
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)271219(10)38227865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/08/2026

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: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 0038227865
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown