MAUDE Adverse Event Report: ANGIODYNAMICS, INC. MINI STICK MAX; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	H965457510
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On [redacted], the physician was performing right internal jugular venous access for a right heart catheterization under ultrasound guidance.According to the medical record, on the second attempt to access, the wire entered a dissection plane just past the needle tip and was unable to be removed from the soft tissue.The wire did not appear to be in the vessel based on fluoroscopy.The physician attempted to maneuver the wire out of the soft tissue without success.The wire tip broke during manipulation and was retained in the soft tissue.The retained foreign object remained in place until [redacted]-4 days later- when it was successfully removed from the tissue surrounding the right internal jugular vein.

• Brand Name: MINI STICK MAX
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• MDR Report Key: 25763010
• Report Number: 25763010
• Device Sequence Number: 16086490
• Product Code: DRE
• UDI-Device Identifier: 15051684022941
• UDI-Public: (01)15051684022941
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/01/2026
• Report Date (Section F): 07/01/2026

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
• Device Model Number: H965457510
• Device Catalogue Number: 45-751
• Device Lot Number: 5855973
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026