MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ChoICE; wire, guide, catheter

Model Number	1960
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove.A choice guidewire was selected as part of treatment of the target lesion.During advancement, the guidewire experienced difficulty crossing the lesion.After the lesion had been crossed, the physician noted resistance and sticking when withdrawing the guidewire.There were no patient complications.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25785682
• Report Number: 2124215-2026-37080
• Device Sequence Number: 18829601
• Product Code: DQX
• UDI-Device Identifier: 08714729150541
• UDI-Public: (01)08714729150541(17)280106(10)38248738
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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 Model Number: 1960
• Device Catalogue Number: 1960
• Device Lot Number: 0038248738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: Not provided; 09/08/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/20/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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