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

Model Number	H749394671500
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guidewire.The 90% stenosed target lesion was located in the severely calcified left anterior descending (lad) artery.A 1.50mm rotapro and rotawire drive were selected for use.The rotawire was crossed into the lad and placed across the lesion.When the burr was advanced, it failed to advance on the wire beyond a certain point just proximal to the non-boston scientific guide catheter.When the physician attempted to withdraw the catheter, it would not move.The wire was hydrated, and the rotapro was pulled with force; but could not be withdrawn.Due to the inability to either withdraw or advance the burr, the entire assembly was withdrawn.The procedure was completed using alternate devices.There were no patient complications.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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; business and technology park,; 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: 50672435
• Report Number: 2124215-2026-47847
• Device Sequence Number: 9539779
• Product Code: MCX
• UDI-Device Identifier: 08714729999577
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749394671500
• Device Catalogue Number: H749394671500
• Device Lot Number: 0040475101
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 05/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Cordis 7F XB 3.5 - Guide Catheter.
• Patient Sex: Unknown