MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	2404-01
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via voluntary medwatch (b)(4) that a device fracture occurred and got dislodged in the lesion.The stenosed target lesion was located in the coronary artery.A comet ii was selected for use.During the procedure, it was noted that the guidewire broke at the end and was dislodged into a coronary artery.The patient required an additional cardiac catheterization procedure to remove the fragment wire.The fragment of the guidewire was removed completely.There were no patient complications reported post procedure.
Additional Manufacturer Narrative
Updated b1.To indicate the event/product problem.Updated g2.To include user facility.Device evaluated by manufacturer: the comet wire returned for analysis.Inspection of the device revealed that there were numerous bends and kinks throughout the body from distal to proximal, additionally, the tip distal was found bent and detached.The device was detached at 3cm from distal to proximal, confirming the reported complaint.
Event or Problem Description
It was reported via voluntary medwatch that a device fracture occurred and got dislodged in the lesion.The stenosed target lesion was located in the coronary artery.A comet ii was selected for use.During the procedure, it was noted that the guidewire broke at the end and was dislodged into a coronary artery.The patient required an additional cardiac catheterization procedure to remove the fragment wire.The fragment of the guidewire was removed completely.There were no patient complication reported post procedure.

• Brand Name: COMET II
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20534765
• Report Number: 2124215-2024-64874
• Device Sequence Number: 8219319
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 01/04/2026
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0033146293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian