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

Model Number	H7491213501J1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that guide wire tip detachment occurred.A 182cm choice guidewire was selected for use.However, upon opening, an anomaly was observed in its structure, and it was noted that the flexible tip was removed.The procedure was completed with another device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: visual and microscopic inspection revealed the spring tip of the guidewire was bent.The total length of the guidewire was within specifications.This means that the guidewire was returned complete for analysis and there was no sign of detachment.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that guide wire tip detachment occurred.A 182cm choice guidewire was selected for use.However, upon opening, an anomaly was observed in its structure, and it was noted that the flexible tip was removed.The procedure was completed with another device.No patient complications were 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22248132
• Report Number: 2124215-2025-37668
• Device Sequence Number: 15851032
• Product Code: DQX
• UDI-Device Identifier: 08714729252412
• UDI-Public: (01)08714729252412(17)260522(10)34088080
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 05/22/2026
• Device Model Number: H7491213501J1
• Device Catalogue Number: H7491213501J1
• Device Lot Number: 0034088080
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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