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

Model Number	H74939359110
Medical Device Problem Codes	Failure to Zero (1683); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Product consisted of an ffr comet pressure wire with the occ cable and torque device.Inspection of the device found the tip of the wire bent.The shroud of the occ cable was connected to the ffr link for signal verification.The signal was not present, as designed.During testing with the ffr link, the signal strength led showed a yellow/orange light, and the zeroed led showed a blinking red light, indicating that the wire was not working appropriately.The shroud of the occ cable was connected to the bench top testing equipment.The modulation was checked but there was no modulation (0%) for this device.Microscopic inspection found the wire was detached from the seam weld.
Event or Problem Description
Reportable based on the device analysis completed on 03jun2025.It was reported that the device failed to be zeroed.The target lesion was located in the coronary artery.An fg comet ii was selected for use for a percutaneous coronary intervention (pci).During the procedure, after the comet wire was connected it gave an error message.The procedure was completed with a non-bsc device.No patient complications were reported, and the patient was stable after the procedure.However, device analysis revealed that the wire was found detached from the seam weld.

• 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: 22324291
• Report Number: 2124215-2025-41722
• Device Sequence Number: 9023264
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: (01)08714729960140(17)270326(10)36154209
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/24/2025

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: 0036154209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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