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

Model Number	2080
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.A choice pt guidewire was selected for use along with a carotid wallstent.The stent was successfully deployed.When the user attempted to remove the stent delivery system from the patient, the delivery system became stuck on the guidewire.The delivery system and guidewire were removed as one unit, and there were no patient complications.
Additional Manufacturer Narrative
Device analysis: the device was returned without the stent loaded on it.Therefore, no signs of entrapment could be found.The body of the guidewire was kinked, and the distal tip was bent.This concluded the product analysis.
Event or Problem Description
It was reported that guidewire entrapment occurred.A choice pt guidewire was selected for use along with a carotid wallstent.The stent was successfully deployed.When the user attempted to remove the stent delivery system from the patient, the delivery system became stuck on the guidewire.The delivery system and guidewire were removed as one unit, and there were no patient complications.
Event or Problem Description
It was reported that guidewire entrapment occurred.A choice pt guidewire was selected for use along with a carotid wallstent.The stent was successfully deployed.When the user attempted to remove the stent delivery system from the patient, the delivery system became stuck on the guidewire.The delivery system and guidewire were removed as one unit, and there were no patient complications.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation result codes: c0706 was removed.H6 - evaluation conclusion codes: the conclusion code was updated from no problem detected to adverse event related to procedure to more accurately reflect the analysis results.Device analysis: the device was returned without the stent loaded on it.Therefore, no signs of entrapment could be found.The body of the guidewire was kinked, and the distal tip was bent.This concluded the product analysis.

• Brand Name: CHOICE 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22668545
• Report Number: 2124215-2025-51753
• Device Sequence Number: 3702479
• Product Code: DQX
• UDI-Device Identifier: 08714729176947
• UDI-Public: (01)08714729176947(17)260710(10)34407907
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/14/2025

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: 07/10/2026
• Device Model Number: 2080
• Device Catalogue Number: 2080
• Device Lot Number: 0034407907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 10/17/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/01/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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