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

Model Number	39615
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire separated.An amplatz super stiff guidewire was selected for use in a biliary drainage procedure.An 8.5 french non-boston scientific drainage catheter for internal and external biliary drainage was used, equipped with a soft mandrin.After correctly positioning the drain, an issue arose while attempting to simultaneously pull out the soft mandrin and the amplatz super stiff guidewire.Resistance was encountered during removal, but the user continued to pull the mandrin and the guidewire out together.Upon extracting the mandrin and guidewire, it was observed that the soft mandrin had stretched during the removal process.Ultimately, a portion of the mandrin was left inside the drainage catheter, and the amplatz super stiff guidewire had disintegrated, separating into two pieces but remaining connected at the midpoint.Both devices were successfully retrieved from the drain.The procedure was not completed due to this event.No patient complications were reported, and the patient's condition was stable following the procedure.
Event or Problem Description
It was reported that the guidewire separated.An amplatz super stiff guidewire was selected for use in a biliary drainage procedure.An 8.5 french non-boston scientific drainage catheter for internal and external biliary drainage was used, equipped with a soft mandrin.After correctly positioning the drain, an issue arose while attempting to simultaneously pull out the soft mandrin and the amplatz super stiff guidewire.Resistance was encountered during removal, but the user continued to pull the mandrin and the guidewire out together.Upon extracting the mandrin and guidewire, it was observed that the soft mandrin had stretched during the removal process.Ultimately, a portion of the mandrin was left inside the drainage catheter, and the amplatz super stiff guidewire had disintegrated, separating into two pieces but remaining connected at the midpoint.Both devices were successfully retrieved from the drain.The procedure was not completed due to this event.No patient complications were reported, and the patient's condition was stable following the procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.It was observed that the coil wire was unraveled.The core wire was found detached and separated from the distal tip to the transition point.The guidewire was also kinked and stretched at the distal section.The reported separation was confirmed.

• 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: 21286860
• Report Number: 2124215-2025-02606
• Device Sequence Number: 7831093
• Product Code: DQX
• UDI-Device Identifier: 08714729115847
• UDI-Public: 08714729115847
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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,Followup
• Report Date (Section B): 03/21/2025

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 Expiration Date: 03/21/2026
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0031286106
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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