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	11/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient underwent percutaneous coronary intervention (pci).A 185cm moderate support straight tip pt2 guidewire was selected for use in the stenting procedure to a lesion in the right coronary artery.The tip of the pt2 guidewire detached.The detached tip remained in the vessel.The procedure was cancelled.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
Additional information stated that there was not a procedural delay, and the procedure was not cancelled.Event description updated to reflect the new information.Removed impact code surgical procedure delayed f1909 and added no health consequences or impact f26.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient underwent percutaneous coronary intervention (pci).A 185cm moderate support straight tip pt2 guidewire was selected for use in the stenting procedure to a lesion in the right coronary artery.The tip of the pt2 guidewire detached.The detached tip remained in the vessel.The procedure was cancelled.No patient harm resulted in relation to this event.It was further reported that the lesion was 60 to 70% stenosed.Mild tortuosity and moderately calcified.There were no snaring attempts, the detached pt2 is lodged in a distal tortuous vessel.There is no impact the blood supply to the heart.The procedure was not cancelled.The event was noticed at the very end of a ptca standard procedure.There were no patient complications.Patient was discharged from hospital two days later.
Event or Problem Description
It was reported that guidewire tip detachment occurred.Procedure summary: the patient underwent percutaneous coronary intervention (pci).A 185cm moderate support straight tip pt2 guidewire was selected for use in the stenting procedure to a lesion in the right coronary artery.The tip of the pt2 guidewire detached.The detached tip remained in the vessel.The procedure was cancelled.Patient status: no patient harm resulted in relation to this event.Additional details: it was further reported that the lesion was 60 to 70% stenosed.Mild tortuosity and moderately calcified.There were no snaring attempts, the detached pt2 is lodged in a distal tortuous vessel.There is no impact the blood supply to the heart.The procedure was not cancelled.The event was noticed at the very end of a ptca standard procedure.There were no patient complications.Patient was discharged from hospital two days later.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The pt2 guidewire was returned and there were no visual damages or detachments were noticed in the device.Dimensional testing was performed and the was measured for the overall length.The device passed measurement specification.Media was provided by the facility.The media revealed ct scans related an unknown anatomy without any device showed.

• Brand Name: PT
• 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: 15965697
• Report Number: 2124215-2022-52131
• Device Sequence Number: 20227295
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: 08714729471196
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2023

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: 03/21/2024
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0029087743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/19/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/03/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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 Age: 44 YR
• Patient Sex: Female