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

Model Number	H749394671250
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire detachment occurred requiring additional intervention.The 22 mm long, 90% stenosed target lesion was located in the severely calcified and severely tortuous ostial circumflex with a diameter of 2.0 to 2.25 mm.A 1.25 mm rotapro and rotawire drive were selected for use.After the third ablation at 180,000 rpm distal to a 90 degree bend, the rotawire detached due to contact with the burr.The detached wire was left in place and a 1.75mm rotapro and additional rotawire were introduced to continue treatment.After three ablations at 180,000 rpm, the guidewires became entangled and the second wire detached.Per the physician, the second wire detachment was also considered to be due to contact with the burr.The entangled wires were securely compressed against the vessel wall with a non-boston scientific stent and the remaining fragments were retrieved via the normal method.The procedure was completed with a different device with no patient injury.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 event of guidewire fracture was 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: the most probable cause for this complaint was considered adverse event related to procedure.As the reported events do not indicate any device damages or failures during unpackaging, preparation, or testing, it was considered likely that the reported events occurred due to factors encountered during the procedure.
Event or Problem Description
It was reported that a wire fracture occurred.The 90% stenosed target lesion with about 22mm lesion length and 2.0mm to 2.25mm target vessel diameter was located in the severely tortuous and severely calcified ostium of circumflex artery.A rotawire floppy 5 pack was selected for use.During procedure, it was noted that the wire fractured at the distal circumflex while performing ablation with a 1.25 mm burr distal to a 90 degrees bend.The fractured wire was left in place, and the ablation was continued with a 1.75mm burr and a second wire.During ablation, the second wire became entangled with the retained first wire and fractured.The two entangled wires were securely compressed against the vessel wall with a stent and the remaining fragments of both fractured wires were retrieved normally.There were no patient complications.

• 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: 24445504
• Report Number: 2124215-2026-10517
• Device Sequence Number: 10254543
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)270811(10)37176890
• 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,Followup
• Report Date (Section B): 04/05/2026

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: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 0037176890
• 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: 01/31/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/05/2026
• Date Device Manufactured: 08/11/2025
• 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: Unknown