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

Model Number	H74939359110
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.Two fg comet ii us were selected for use.During procedure, no reading would come up with the two comet wires.The procedure was aborted.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device revealed that the wire was detached from the sensor.Since the occ cable did not return, an occ cable testing was used and 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 led lights for a properly working wire are green.Since to the occ cable did not return, an occ cable testing was used and connected to the bench top testing equipment.The modulation was checked but there was no modulation (0%) for this device.
Event or Problem Description
It was reported that the procedure was cancelled.Two fg comet ii us were selected for use.During procedure, no reading would come up with the two comet wires.The procedure was aborted.No complications were reported.

• 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: 20893046
• Report Number: 2124215-2024-77381
• Device Sequence Number: 20813538
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: Other
• Device Expiration Date: 10/01/2026
• Device Model Number: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 0034964978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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