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

Model Number	H74939359110
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred, resulting in an unretrieved device fragment.The target lesion was located in the right coronary artery.A comet ii was selected for use.During the procedure, a comet wire was inserted for fractional flow reserve (ffr) assessment.The physician noted that the vessel was not difficult to wire, and no issues were encountered with wire manipulation during insertion.However, upon completion of the testing, the wire became stuck and broke at the tip while still inside the patient.Attempts to retrieve the broken segment were unsuccessful, leading the physician to stent the vessel in order to tack the wire tip against the vessel wall.The procedure was completed using an alternative method by placing the stent over broken wire tip.The patient was stable post procedure, however, was admitted to the hospital beyond the standard of care with discharge on an unknown date.
Event or Problem Description
It was reported that tip detachment occurred, resulting in an unretrieved device fragment.The target lesion was located in the right coronary artery.A comet ii was selected for use.During the procedure, a comet wire was inserted for fractional flow reserve (ffr) assessment.The physician noted that the vessel was not difficult to wire, and no issues were encountered with wire manipulation during insertion.However, upon completion of the testing, the wire became stuck and broke at the tip while still inside the patient.Attempts to retrieve the broken segment were unsuccessful, leading the physician to stent the vessel in order to tack the wire tip against the vessel wall.The procedure was completed using an alternative method by placing the stent over broken wire tip.The patient was stable post procedure, however, was admitted to the hospital beyond the standard of care with discharge on an unknown date.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Inspection of the device revealed that the body was kinked at 38cm from distal to proximal, additionally the wire returned detached from the sensor, this part did not return for analysis.

• 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: 21955549
• Report Number: 2124215-2025-26980
• Device Sequence Number: 13058529
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: (01)08714729960140(17)260606(10)34181147
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2026
• Device Model Number: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 0034181147
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male