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

Model Number	39615
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 19nov2025.An 0.035in x 260cm x 3mm amplatz super stiff guidewire was selected for use.During introduction, the guidewire could not cross the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed peeled coating on the guidewire.
Additional Manufacturer Narrative
E1 - initial reporter address : (b)(6).Device evaluated by mfr: the amplatz super stiff guidewire was returned for analysis.Visual and microscopic inspection of the device revealed that the coating was peeled along the guidewire.Additionally, under magnification, it was observed that there were some jumped coils in the guidewire.

• 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: 23807102
• Report Number: 2124215-2025-87467
• Device Sequence Number: 7707606
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: (01)08714729115861(17)271128(10)35383190
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0035383190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 65 KG