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

Model Number	2783
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire fracture occurred.A 300cm j-tip pt2 guidewire was selected for use during a vascular angioplasty.During preparation it was noticed that the guidewire was broken.The procedure was completed using another similar device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch.Overall visual revision the unit returned split in two pieces.Product analysis performed.The returned device matches with the upn and lot number provided by the customer.Guidewire was found detached visually and microscopically.This could be related to an excessive force applied to the device, as well as operational factors such as handling/technique contributing to the observed damage.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that a guidewire fracture occurred.A 300cm j-tip pt2 guidewire was selected for use during a vascular angioplasty.During preparation it was noticed that the guidewire was broken.The procedure was completed using another similar device.There were no patient complications 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: 17691706
• Report Number: 2124215-2023-46708
• Device Sequence Number: 6378244
• Product Code: DQX
• UDI-Device Identifier: 08714729471240
• UDI-Public: 08714729471240
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 06/22/2024
• Device Model Number: 2783
• Device Catalogue Number: 2783
• Device Lot Number: 0029648177
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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
• Patient Sex: Unknown