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

Model Number	H74939359110
Medical Device Problem Codes	Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
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 tip was found bent.The appearance of the bend is consistent to damage that can be caused from interaction with another device, the patient's anatomy, or handling the device during the procedure.The optical cable did not return with the ffr comet pressure wire, a testing cable was used and connected to the bench top testing equipment.A device-to-device interaction test was performed, and the signal was not present as expected, when connected to the ffr link for signal verification.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.Additionally, during functional testing, the modulation was checked but there was no modulation (0%) for this device.During microscopic testing, the sensor was found to be damaged.Based on the investigation of the returned device, the reported event of no pressure signal, which caused a procedure cancellation, can be confirmed.The damaged sensor could have contributed to the event.
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: 20893013
• Report Number: 2124215-2024-77382
• Device Sequence Number: 7772701
• 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): 02/10/2025

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: 01/21/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/10/2025
• 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