MAUDE Adverse Event Report: ANGIODYNAMICS, INC ANGIODYNAMICS; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	45751
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	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A risk manager submitted a user facility medwatch, reference (b)(4), for a mini stick max 4f x 10 cm stiff.018 ss/ss echo 2.75" pg.The physician was attempting to gain access to right popliteal vein with micropuncture access wire; however, when attempting to remove the needle and wire, the distal end of the micropuncture wire became knotted and stuck within the access tract.According to the patient's medical record, the physician attempted gentle manipulation and shallow dissection; however, the wire snapped below the skin surface, at the level of the knot.The soft, flexible opaque tip, measuring <0.5cm, remained within the skin tract and was unable to be retrieved.At this time, there is no known injury to the patient and no plans to remove the fragment as it is not posing any issues.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of the guidewire was detached was confirmed, however, the returned product is not an angiodynamics product.This information was communicated to the complaint reporter, however, their response was 'that was the product documented in their medical record and no further details could be provided.' no further complaint investigation is required since this is not an angiodynamics provided product.Reference (b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21773180
• Report Number: 1317056-2025-00096
• Device Sequence Number: 8087072
• Product Code: DRE
• UDI-Device Identifier: H965457510
• UDI-Public: H965457510
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 45751
• Device Lot Number: 5828535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 07/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: 52 YR
• Patient Sex: Male