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	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that guidewire fracture occurred.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the coating on wire was unraveled, coming off of wire and breaking.The device was removed from the patient.No patient harm was reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the guidewire was returned, and it was observed that the coil wire was unraveled due the core wire being detached separated from distal tip to the transition point.Also, the guidewire was kinked and stretched at distal section.Media review revealed that the core wire was separated from the bald weld, and that the guidewire was stretched and bent at the distal section.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that guidewire fracture occurred.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the coating on wire was unraveled, coming off of wire and breaking.The device was removed from the patient.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: 21454113
• Report Number: 2124215-2025-07364
• Device Sequence Number: 17931798
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: (01)08714729115946(17)271002(10)34980251
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 0034980251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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