MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Comet¿ II; Wire, guide, catheter

Model Number	H74939359110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ffr "[fractional flow reserve]" procedure was being performed on patient.The tip of the ffr wire broke inside the patient's coronary artery.It was retrieved with a snare; a dissection of the artery was caused, and the vessel was stented.Patient remained stable the entire procedure.

• Brand Name: Comet¿ II
• Common Device Name: Wire, guide, catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 50150415
• Report Number: 50150415
• Device Sequence Number: 9407857
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: (01)08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2026
• Report Date (Section F): 07/23/2026

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
• Device Model Number: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 34316310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 07/30/2026