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

Model Number	39575
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire protruded about 3 cm from the tip.The 50% stenosed target lesion was located in the mildly tortuous vessel.A 035/260 amplatz super stiff guidewire was selected for endovascular thrombectomy (evt) procedure.During the procedure, it was noted that the wire protruded about 3 cm from the tip.The procedure was completed with another of the same device.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was it was 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 at distal section.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the wire protruded about 3 cm from the tip.The 50% stenosed target lesion was located in the mildly tortuous vessel.A 035/260 amplatz super stiff guidewire was selected for endovascular thrombectomy (evt) procedure.During the procedure, it was noted that the wire protruded about 3 cm from the tip.The procedure was completed with another of the same device.No patient injury was reported.

• 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: 21710995
• Report Number: 2124215-2025-16266
• Device Sequence Number: 4539341
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• UDI-Public: (01)08714729115830(17)270704(10)34372917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843016
• 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): 05/20/2025

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: 0034372917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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