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	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was canceled.A comet ii pressure guide wire was selected for use.Upon using the comet ii pressure guidewire, the blue line on the screen dropped out.They turned the system off then back on, they tried unplugging the wire then plugging it back in then they switched out wires and the problem still existed.The procedure was not completed.Due to this.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer.Returned product consisted of an ffr comet pressure wire with the occ cable.During memory test, the shroud of the occ cable was connected to the bench top testing equipment.The rfid tag associated with this device and the coefficient values were confirmed to be programmed.During device-to device interaction, the shroud of the occ cable was connected to the ffr link to verify the signal strength.There were no issues in connecting to the ffr link.The signal was present, and the signal strength and the zeroed led lights showed green, as designed.The green led lights indicated the wire was working properly.The device was then connected to the polaris (ilab) test equipment via bluetooth signal.The wire communicated to the polaris system and zeroed, as designed.With the wire inserted into the test pressure chamber, the wire transferred a pressure waveform to the polaris which indicates a functioning wire.A visual inspection of the device revealed that there were numerous kinks throughout the body from distal to proximal, additionally the tip was found bent.No other issues were identified during the product analysis.During functional test, the shroud of the occ cable was connected to the bench top testing equipment.The modulation was checked and was 14.8%.The wire was inserted into the pressure chamber.The pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the procedure was canceled.A comet ii pressure guide wire was selected for use.Upon using the comet ii pressure guidewire, the blue line on the screen dropped out.They turned the system off then back on, they tried unplugging the wire then plugging it back in then they switched out wires and the problem still existed.The procedure was not completed.Due to this.No patient 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: 21562299
• Report Number: 2124215-2025-13690
• Device Sequence Number: 15768578
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/22/2025

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 Expiration Date: 08/26/2026
• Device Model Number: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 0034711496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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