MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	2404-01
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a wire fracture occurred.The target lesion was located in the moderately tortuous left anterior descending artery.A comet ii pressure guidewire was selected for use.During the procedure, the wire could not advance in the lesion, so the device was removed, and it was noticed that the 3cm radiopaque tip was no longer attached to the wire.Everything was removed from the patient and the tip was found trapped in the distal guide catheter.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).An incomplete device was returned for analysis.Visual inspection revealed that the wire was detached at 3.5cm from distal to proximal.The body of the wire was found bent / kinked at 142cm from distal to proximal.
Event or Problem Description
It was reported that a wire fracture occurred.The target lesion was located in the moderately tortuous left anterior descending artery.A comet ii pressure guidewire was selected for use.During the procedure, the wire could not advance in the lesion, so the device was removed, and it was noticed that the 3cm radiopaque tip was no longer attached to the wire.Everything was removed from the patient and the tip was found trapped in the distal guide catheter.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: COMET II
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20311502
• Report Number: 2124215-2024-57739
• Device Sequence Number: 8686456
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 11/13/2024

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: 03/19/2026
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0033657899
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: Male