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

Model Number	39695
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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 the guidewire became entrapped.An amplatz super stiff guidewire was selected for a percutaneous nephrostomy drain exchange procedure.The device was inserted at the proximal end of a non-bsc nephrostomy drain.The device became stuck inside the non-bsc nephrostomy drain, and the device's coating became loose.Both the non-bsc nephrostomy drain, and device had to be removed from the patient together.No fragments were left inside of the patient.A different device of the same model was used to complete the procedure.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the amplatz super stiff guidewire was returned to the quality assurance laboratory for analysis.Visual inspection revealed that the guidewire was entrapped and stuck inside a non-bsc stent.Microscopic inspection revealed that the ptfe coating was peeled.
Event or Problem Description
It was reported the guidewire became entrapped.An amplatz super stiff guidewire was selected for a percutaneous nephrostomy drain exchange procedure.The device was inserted at the proximal end of a non-boston scientific nephrostomy drain.The device became stuck inside the non-boston scientific nephrostomy drain, and the device's coating became loose.Both the non-boston scientific nephrostomy drain, and device had to be removed from the patient together.No fragments were left inside of the patient.A different device of the same model was used to complete the procedure.There were no patient complications as a result of the 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21791259
• Report Number: 2124215-2025-20623
• Device Sequence Number: 12969102
• Product Code: DQX
• UDI-Device Identifier: 08714729295754
• UDI-Public: 08714729295754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0034166994
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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