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

Model Number	39695
Medical Device Problem Codes	Unraveled Material (1664); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr: the device was returned for analysis.A comprehensive visual inspection did not reveal any failures or evidence that may have been compromised during the decontamination process.Upon visual examination of the returned guidewire, it was noted that the distal tip was bent.Additionally, microscopic inspection revealed that the guidewire appeared unraveled, and the coating was peeled.
Event or Problem Description
Reportable based on the device analysis completed on 16apr2025.It was reported that coil wire was unraveled.An amplatz super stiff guidewire was selected for use to exchange a nephrostomy drainage catheter.The nephrostomy drainage catheter was successfully removed; however, the new nephrostomy drainage catheter was unable to track over the amplatz super stiff guidewire.The nephrostomy drainage catheter was then able to be exchanged without the stiffener in the correct place.Upon examining the amplatz super stiff guidewire, it appeared that the thread had come away halfway down the wire which had made the procedure more challenging.The procedure was completed and there were no patient complications as a result of this event.However, device analysis revealed that the coating was peeled.

• 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: 22031093
• Report Number: 2124215-2025-29015
• Device Sequence Number: 21005544
• Product Code: DQX
• UDI-Device Identifier: 08714729114604
• UDI-Public: (01)08714729114604(17)271217(10)35505795
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K843018
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0035505795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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: Female