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

Model Number	2000
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	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that distal tip fracture occurred.During preparation of a 182cm j choice floppy guidewire, the tip was found to be fractured.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event: use the first day of the month of the aware date as the event date, as it was not provided.
Additional Manufacturer Narrative
B3: date of event: use the first day of the month of the aware date as the event date, as it was not provided.Device evaluated by mfr: returned product consisted of choice floppy 182cm j guidewire.Visual and microscope inspection reveals that the spring tip was observed bent and stretched.No issues could be found that can be related to the reported issue and the reported complaint is not confirmed.
Event or Problem Description
It was reported that distal tip fracture occurred.During preparation of a 182cm j choice floppy guidewire, the tip was found to be fractured.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: CHOICE
• 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: 18152169
• Report Number: 2124215-2023-62878
• Device Sequence Number: 6467308
• Product Code: DQX
• UDI-Device Identifier: 08714729252351
• UDI-Public: 08714729252351
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 04/21/2025
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 0031478078
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2023
• 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: Unknown