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

Model Number	45753
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
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.Reference (b)(4).
Event or Problem Description
Angiodynamics received notification of an event that an end user experienced with a mini stick max 4f x 10 cm stiff.018 ni/tu echo 2.75".During a procedure, a portion of the sheath cannula broke off inside the patient prior to the exchange of the 9fr sheath.Attempts were made to retrieve the translucent piece with a snare.Hospitalization was needed due to this event.There was no report of patient harm.

• 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: 25096737
• Report Number: 1319211-2026-00161
• Device Sequence Number: 18583674
• Product Code: DRE
• UDI-Device Identifier: H965457530
• UDI-Public: H965457530
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45753
• Device Lot Number: 5860435
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/01/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White