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

Model Number	H749394671750
Medical Device Problem Codes	Nonstandard Device (1420); Improper Flow or Infusion (2954); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Investigation results: device analysis findings: inspection of the device found that there were numerous kinks present in the coil and sheath.After destructive testing was performed, it was found that the sheath was torn and buckled up to approximately 2cm distal from the burr housing strain relief.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was completed and confirmed that the events of device leaks (back bleeding occurs) and devie stall were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.The reported event indicated that there were a saline infusion issue and the device stalled during ablation inside the patient.Product analysis confirmed the reported events, as the sheath was torn and the coil and sheath were kinked.It was considered likely that the damaged sheath was related to the reported infusion issues, and the damaged coil was related to the device stall.As a review of the dhr shows that the device was manufactured per specification, review of the instructions for use indicates that the device is not to be used if damages or defects are identified prior to use, and the reported events do not indicate any damages or defects to the device during unpackaging or preparation, it was considered likely that the reported events and identified damages to the device occurred due to factors encountered during the procedure.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that blood flows back from the tip.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery (lca).A 1.75mm rotapro was selected for use.During rotation speed adjustment and ablation, the stall lamp illuminates.The rota cocktail flows at an abnormally rapid rate.Blood flows back from the tip.The target speed was at 180,000 and the actual speed was at 60,000 to 90,000 rpm during normal and dynaglide mode.The procedure was completed with this device.There were no patient complications.However, device analysis revealed that the sheath was torn.

• 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 ; 7634941632
• MDR Report Key: 24801148
• Report Number: 2124215-2026-18770
• Device Sequence Number: 21509715
• Product Code: MCX
• UDI-Device Identifier: 08714729999584
• UDI-Public: (01)08714729999584(17)270710(10)36939010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• 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): 04/07/2026

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: H749394671750
• Device Catalogue Number: H749394671750
• Device Lot Number: 0036939010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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
• Patient Sex: Male