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	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment and unretrieved device fragment occurred.The patient presented with coronary stenosis.A 182cm pt graphix guidewire was selected for use.However, the guidewire fractured approximately between body and tip.The guidewire tip deprecated from wire body.The detached portion was removed; but a portion remained inside the patient.The procedure was not completed as the patient was sent for transthoracic surgery due to complication.No further patient complications were reported.
Event or Problem Description
It was reported that guidewire tip detachment and unretrieved device fragment occurred.The patient presented with coronary stenosis.A 182cm pt graphix guidewire was selected for use.However, the guidewire fractured approximately between body and tip.The guidewire tip deprecated from wire body.The detached portion was removed; but a portion remained inside the patient.The procedure was not completed as the patient was sent for transthoracic surgery due to complication.No further patient complications were reported.It was further reported that wire tip dislodged from wire body and could not be retrieved percutaneously.Moreover, the percutaneous coronary intervention (pci) was discontinued in leu of the surgery.
Additional Manufacturer Narrative
B5 describe event or problem updated.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16295077
• Report Number: 2124215-2023-02914
• Device Sequence Number: 17650700
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/16/2023
• 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