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

Model Number	H749394671500
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Difficult to Remove (1528); Material Separation (1562); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device detached requiring additional surgery.The 90% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery (rca).A 1.50 mm rotapro and rotawire were selected for treatment.Dynaglide mode was initiated and the device was advanced just proximal to the lesion.After several ablations, the burr became stuck in the lesion and the device stalled.The device remained stuck in the lesion and in a stalled state despite many attempts to free the burr by initiating rotation in dynaglide mode.The advancer was then pulled, resulting in separation of the burr.After removal of the device from the body, it was confirmed that the rotawire had also separated approximately 30 cm from the tip within the guide catheter.The fragment migrated to the aorta and could not be retrieved via snare.Retrieval of the burr was attempted by inserting a trapping balloon and pulling the guide catheter, but the device remained stuck in the lesion.An additional guide catheter was inserted via an alternate vascular access site and a guidewire was then advanced to the lesion using the double-guide technique.Dilation with a small diameter balloon was performed, but the burr remained stuck within the lesion.The patient was transferred to another facility for surgical intervention.A thoracotomy was performed to retrieve the device fragments followed by a bypass procedure.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 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: 50588247
• Report Number: 2124215-2026-46449
• Device Sequence Number: 10068312
• Product Code: MCX
• UDI-Device Identifier: 08714729999577
• UDI-Public: (01)08714729999577(17)271124(10)38034551
• 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): 09/29/2026

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: 0038034551
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2025
• 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