MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS; MINI STICK MAX COAXIAL MICROINTRODUCER KIT

Model Number	45751
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue when using a mini stick max 4f x 10 cm stiff.018 ss/ss echo 2.75".It was reported that there have been several cases in which there was vessel injury during insertion.Additionally, it was reported that at this stage, they were unable to determine whether these incidents were related to the item itself or to procedural and user-related factors.It has been decided in the radiology department for the item to be used on the vein and not the artery.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: MINI STICK MAX COAXIAL MICROINTRODUCER KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 603 queensbury avenue; queensbury, NY 12803
• MDR Report Key: 25634691
• Report Number: 1319211-2026-00218
• Device Sequence Number: 9353191
• Product Code: DRE
• UDI-Device Identifier: H965457510
• UDI-Public: H965457510
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 45751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown