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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 185cm pt2 guidewire was selected for use.The wire was attempted to be advanced up the radial artery; however, while advancing the wire, the transition of the floppy tip to the stiffer portion of the wire was fractured.The device was retrieved with a snare.A new pt2 guidewire was then used; however, when the insertion was attempted, the new guidewire tip also fractured.A replacement wire of a different type was used, and the procedure was completed successfully.Following the procedure, while the third pt2 wire was examined in the control room, the tip of the guidewire was fractured.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was visually and microscopically examined.The proximal section of the wire was kinked; and the distal tip was bent.The reported guidewire fracture is confirmed as the distal section of the wire was found detached.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 185cm pt2 guidewire was selected for use.The wire was attempted to be advanced up the radial artery; however, while advancing the wire, the transition of the floppy tip to the stiffer portion of the wire was fractured.The device was retrieved with a snare.A new pt2 guidewire was then used; however, when the insertion was attempted, the new guidewire tip also fractured.A replacement wire of a different type was used, and the procedure was completed successfully.Following the procedure, while the third pt2 wire was examined in the control room, the tip of the guidewire was fractured.No patient complications were reported.

• 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: 18711576
• Report Number: 2124215-2024-05488
• Device Sequence Number: 7255420
• Product Code: DQX
• UDI-Device Identifier: 08714729471219
• UDI-Public: 08714729471219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2025
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0030779421
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Female