MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET? II; WIRE, GUIDE, CATHETER

Model Number	H74939359110
Medical Device Problem Codes	Nonstandard Device (1420); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Inspection of the device revealed that the body was detached at 38cm from distal to proximal, additionally the tip was found bent.The shroud of the occ cable was connected to the bench top testing equipment, and the coefficient values were confirmed to be programmed.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.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to procedure following a review of the reported event details, available information, and product record review.During product analysis it was observed the body detached and the tip bent, these issues could be related to an excessive force applied to the device during procedure, as well as operational factors such as handling/technique causing the reported event.
Event or Problem Description
Reportable based on the device analysis completed on 17feb2026.It was reported that the device would not equalize.The stenosed target lesion was located in the left anterior descending artery.A comet ii guidewire was selected for use.During the procedure, it was noted that the wire would not equalize.The procedure was completed with another pressure guidewire.There were no patient complications reported post procedure.However, device analysis revealed a detached wire.

• Brand Name: COMET? II
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 24514178
• Report Number: 2124215-2026-12121
• Device Sequence Number: 20961086
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: (01)08714729960140(17)271009(10)37659556
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 0037659556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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