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

Model Number	2779
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that device fracture occurred.During the unpacking of 185cm pt2 guidewire, it was observed that the wire split up but did not break off.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for the analysis.Visual and microscopic inspection revealed the distal section was bent.No issues could be observed that can be related to the reported issue.
Event or Problem Description
It was reported that device fracture occurred.During the unpacking of 185cm pt2 guidewire, it was observed that the wire split up but did not break off.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.

• 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: 18615985
• Report Number: 2124215-2024-02365
• Device Sequence Number: 7478928
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: 08714729471103
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 02/19/2025
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0031085641
• 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: 01/15/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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 Sex: Male