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

Model Number	1960
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	05/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).B2 date of death: earliest possible date of death was used.Exact date remains unknown.
Event or Problem Description
It was reported that the device detached and the patient died.The patient presented with coronary artery disease.During percutaneous intervention, a 182cm choice guidewire was advanced and the tip of the guidewire broke off in the circumflex artery.Instead of removing the 6mm device fragment, the physician decided to press a portion of the guidewire tip to the vessel wall using a stent.The entire length of the device fragment could not be stented to the vessel wall.The patient remained stable during the procedure.The following day, diagnostic coronary angiography revealed that the lumen of the artery was normal, blood flow was not limited.The patient was transferred to another hospital for additional intervention.Two additional stents were deployed in the circumflex pressing the remainder of the guidewire tip against the vessel wall.Thrombosis then occurred resulting in the death of the patient.

• Brand Name: CHOICE
• 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: 19745390
• Report Number: 2124215-2024-42286
• Device Sequence Number: 6513349
• Product Code: DQX
• UDI-Device Identifier: 08714729150558
• UDI-Public: 08714729150558
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 07/15/2024

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: 07/15/2024
• Device Model Number: 1960
• Device Catalogue Number: 1960
• Device Lot Number: 0029777233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/15/2024
• Date Device Manufactured: 07/16/2022
• 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: Death
• Patient Sex: Unknown