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

Model Number	H74939359110
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device entrapment and dissection occurred.The stenosed target lesion was located in the distal left anterior descending (lad) artery.A comet ii pressure guidewire was selected for use.During removal of the wire, the wire tip was caught and entangled in a previously placed, under deployed stent in the distal lad artery.Despite of normal removal technique, the wire tip separated from the wire and became lodged on a stent strut and caused a dissection.The separated tip was left in the lad.Attempts to deliver and deploy an additional stent at the affected site were unsuccessful.Balloon percutaneous transluminal coronary angioplasty (ptca) was performed to complete the procedure, and the patient condition was stable.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of an ffr comet pressure wire.The wire returned detached from the weld seam and tip distal, the tip distal part did not return for analysis.The occ cable was not returned for the analysis.Inspection of the device revealed that there were numerous kinks throughout the body from distal to proximal, additionally, the wire was found detached from the weld seam at 36cm from distal to proximal, also, the tip distal was found detached.
Event or Problem Description
It was reported that device entrapment and dissection occurred.The stenosed target lesion was located in the distal left anterior descending (lad) artery.A comet ii pressure guidewire was selected for use.During removal of the wire, the wire tip was caught and entangled in a previously placed, under deployed stent in the distal lad artery.Despite of normal removal technique, the wire tip separated from the wire and became lodged on a stent strut and caused a dissection.The separated tip was left in the lad.Attempts to deliver and deploy an additional stent at the affected site were unsuccessful.Balloon percutaneous transluminal coronary angioplasty (ptca) was performed to complete the procedure, and the patient condition was stable.No further 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: 21938289
• Report Number: 2124215-2025-24802
• Device Sequence Number: 12101168
• Product Code: DQX
• UDI-Device Identifier: 08714729960140
• UDI-Public: (01)08714729960140(17)260829(10)34741393
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/03/2025

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: 08/29/2026
• Device Model Number: H74939359110
• Device Catalogue Number: H74939359110
• Device Lot Number: 0034741393
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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 Sex: Unknown