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

Model Number	39575
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guidewire had become detached.The procedure involved an atrial septal defect (asd), and a 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.During delivery, significant resistance prevented the advancement of the guidewire.Upon removal, it was discovered that the tip of the guidewire had detached and become incomplete due to a detachment of its loop; however, it did not break.The patients anatomy was not considered challenging, and neither patient nor procedural factors contributed to the reported event.The lesion exhibited no stenosis, tortuosity, or calcification.The device was removed by pulling it out directly, with no fragment left inside the patient.The procedure was successfully completed with a different device, and no patient complications were noted as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the tip of the guidewire had become detached.The procedure involved an atrial septal defect (asd), and a 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.During delivery, significant resistance prevented the advancement of the guidewire.Upon removal, it was discovered that the tip of the guidewire had detached and become incomplete due to a detachment of its loop; however, it did not break.The patients anatomy was not considered challenging, and neither patient nor procedural factors contributed to the reported event.The lesion exhibited no stenosis, tortuosity, or calcification.The device was removed by pulling it out directly, with no fragment left inside the patient.The procedure was successfully completed with a different device, and no patient complications were noted as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).The device was returned for analysis.Visual inspection identified that the distal tip of the device was bent.The media attached to the parent record also confirmed the distal tip deformation, as the distal tip was visibly bent.

• 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: 24079769
• Report Number: 2124215-2026-02736
• Device Sequence Number: 5816649
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: (01)08714729295655(17)280103(10)35553476
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 0035553476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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