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

Model Number	39575
Medical Device Problem Codes	Unraveled Material (1664); 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	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The amplatz super stiff was not returned but device analysis was performed using the photo received.There were pictures attached in the parent record, it was possible to observed that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point, also, the guidewire was kinked and stretched at distal section.
Event or Problem Description
It was reported that tip damage occurred.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the tip part of the wire was shredded.The wire was removed, and the procedure was completed with a new wire.There were no patient complications as a result of this event.It was further reported that the tip was uncoiling off of the core wire.
Event or Problem Description
It was reported that tip damage occurred.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the tip part of the wire was shredded.The wire was removed, and the procedure was completed with a new wire.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: 22125702
• Report Number: 2124215-2025-33855
• Device Sequence Number: 7292360
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: (01)08714729115946(17)280222(10)35917868
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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 Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0035917868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 02/22/2025
• 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