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

Model Number	2520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch report mw5115812 that distal tip detachment occurred.A 182cm choice pt graphix guidewire was used during a left heart catheterization.However, while the wire was being removed, the tip of the wire sheared off.The device fragment was retained inside the vessel.Subsequently, coronary artery bypass graft surgery (cabg) was performed for three times.No patient complications were reported.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16724184
• Report Number: 2124215-2023-15184
• Device Sequence Number: 7949917
• Product Code: DQX
• UDI-Device Identifier: 08714729254935
• UDI-Public: 08714729254935
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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: 08/09/2024
• Device Model Number: 2520
• Device Catalogue Number: 2520
• Device Lot Number: 0029924575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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: Required Intervention
• Patient Sex: Unknown