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

Model Number	39575
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the peripheral artery.An amplatz super stiff was selected for treatment.During the procedure, advancement of the amplatz wire within the patient proved challenging.Upon removal of the wire, it was observed that the coating had become bunched up and exhibited a lumpy texture.The procedure was subsequently completed using an alternative device of the same type.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the lower leg extremity vein.An amplatz super stiff guidewire was selected for treatment.During the procedure, advancement of the guidewire within the patient proved challenging.Upon removal of the guidewire, it was observed that the coating had become bunched up and exhibited a lumpy texture.The procedure was subsequently completed using an alternative device of the same type.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Correction mdr for the following: b5: anatomy location and specifying the word guidewire.E1: initial reporter zip code.H6:device codes for advancing issue and conclusion code.

• 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: 21774046
• Report Number: 2124215-2025-20889
• Device Sequence Number: 15907918
• Product Code: DQX
• UDI-Device Identifier: 08714729115823
• UDI-Public: (01)08714729115823(17)271203(10)35410020
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K843014
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 0035410020
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 12/03/2024
• 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