MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal tip detachment occurred resulted in un-retrieved device fragment in patient.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified obtuse marginal branch.A 185cm pt2 guidewire was selected for used.Upon removal of the wire, the distal tip, separated from the main wire, and was left in the distal artery.No attempt was made to retrieve the wire from the patient, as it remains in a small vessel.A different wire was placed in the same vessel, and the procedure was completed successfully.No patient complications were reported.
Event or Problem Description
It was reported that distal tip detachment occurred resulted in un-retrieved device fragment in patient.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified obtuse marginal branch.A 185cm pt2 guidewire was selected for used.Upon removal of the wire, the distal tip, separated from the main wire, and was left in the distal artery.No attempt was made to retrieve the wire from the patient, as it remains in a small vessel.A different wire was placed in the same vessel, and the procedure was completed successfully.No patient complications were reported.The event was further reported via facility medwatch report mw5152789.The distal end of the wire broke off in the coronary artery.Additionally, due to the location of the broken piece, removal of the wire was not appropriate, and no serious injury was anticipated for the patient.
Additional Manufacturer Narrative
Updated b5: describe event or problem corrected the following: e4: init rptr also sent rep to fda, and g2: report source.

• Brand Name: PT
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19029147
• Report Number: 2124215-2024-16288
• Device Sequence Number: 18189481
• Product Code: DQX
• UDI-Device Identifier: 08714729471134
• UDI-Public: 08714729471134
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 10/05/2024
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0030291012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: Other
• Patient Sex: Unknown