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

Model Number	H74939359110
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterile package was open.A fg comet ii pressure guidewire was selected for use.During unpacking, it was noted that the sterile package was open.The box on the outside was closed and the blue sticker was intact.The procedure was completed using an alternative method.No complications were reported, and patient is stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection found no damage or irregularities in the pouch as well as in the device.Based on the evidence the ar packaging, unsealed device packaging is not confirmed.
Event or Problem Description
It was reported that sterile package was open.A fg comet ii pressure guidewire was selected for use.During unpacking, it was noted that the sterile package was open.The box on the outside was closed and the blue sticker was intact.The procedure was completed using an alternative method.No complications were reported, and patient is stable post procedure.

• 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: 22075564
• Report Number: 2124215-2025-31893
• Device Sequence Number: 12939479
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: (01)08714729960140(17)260911(10)34824819
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 09/11/2026
• Device Model Number: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 0034824819
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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