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

Model Number	H749394671500
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck in the lesion and detachment occurred, requiring additional intervention.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified circumflex artery.A rotapro 1.50mm was selected for use.After approximately 10 20 second runs, the burr did not completely cross the lesion and became lodged.The physician was initially unable to withdraw the burr but was able to free it by restarting rotation.The physician then stopped burring and attempted to dynaglide out, using the guidewire to withdraw the burr back into the guide catheter.The vessel was parallel wired with a non-boston scientific guidewire to secure the circumflex while the rota catheter was walked out.It was then noted that the sheath and drive shaft were coming out of the guide while the burr remained in the distal portion of the guide catheter near the left main.All components of the device were successfully removed along with the guide catheter.A new guide catheter was inserted, additional vessel preparation was performed with a 3.0mm x 10mm wolverine balloon, and the procedure was completed with implantation of a 3.5mm x 28mm megatron stent.There were no patient complications, and the patient was stable 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 Corporatio; business and technology park,; cork, T12 Y K88; AS T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave nselat; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50569996
• Report Number: 2124215-2026-46386
• Device Sequence Number: 10507885
• Product Code: MCX
• UDI-Device Identifier: 08714729999577
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: H749394671500
• Device Catalogue Number: H749394671500
• Device Lot Number: 0038504282
• 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: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 02/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.0mm x 10mm Wolverine - Balloon; 3.5mm x 28mm Megatron - Strent; Sion Blue -Guidewire
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown