MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39575
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	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.An amplatz super stiff guidewire was selected for use.During the course of the procedure, it was noted that the two fibers were protruding near the tip of the guidewire.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that it was possible to observed that the core wire was detached and two fibers were protruding near the tip of the guidewire, moreover the distal tip was kinked.Media inspection revealed that the core wire was detached, and two fibers were protruding near the tip of the guidewire, moreover the distal tip was kinked.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that tip detachment occurred.An amplatz super stiff guidewire was selected for use.During the course of the procedure, it was noted that the two fibers were protruding near the tip of the guidewire.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: AMPLATZ SUPER STIFF
• 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: 22168860
• Report Number: 2124215-2025-33938
• Device Sequence Number: 18100167
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: (01)08714729295655(17)271107(10)35239036
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843012
• 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): 07/09/2025

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 Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0035239036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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