MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Amplatz Super Stiff; Wire, Guide, Catheter

Model Number	39575
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.The non-stenosed target lesion was located in the severely tortuous and non-calcified thoracic descending aorta.An amplatz super stiff guidewire was selected for use.During the procedure, a non-bsc stent graft was inserted into the guidewire lumen, however, it was very difficult to remove after the graft had been placed.The catheter and guide wire were removed separately.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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50788913
• Report Number: 2124215-2026-49366
• Device Sequence Number: 9415419
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 0038708429
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 02/27/2026
• 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: Male