MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO; BIOFLO PICC WITH ENDEXO TECHNOLOGY

Model Number	45876
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that 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
A distributor reported an end user experienced an issue when using a bio-stable 4f sl 55cm mst-70 kit non-valved.During picc placement, the stainless steel guidewire fractured into two separate pieces inside the patient.The wire had unraveled prior to fracturing due to the extended time of manipulating the wire and trying to free it from the collateral.They were unable to remove the retained fragment from the patient's right arm within the collateral vein connected to the brachial vein.The collateral was small and tortuous, and had spasmed.They believe the fragment will not migrate from that position.The procedure was successfully completed with another of the same device.The patient was informed of the event and reported to have no concerns at that time.It had been reported the patient had a nickel allergy.The patient did not experience any harm as a result of this incident.

• Brand Name: BIOFLO
• Common Device Name: BIOFLO PICC WITH ENDEXO TECHNOLOGY
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: ashleigh ashleigh garcia ; 50 main street; suite 1000; white plains, NY 10606 ; 8134543296
• MDR Report Key: 24116888
• Report Number: 1319211-2026-00008
• Device Sequence Number: 5987173
• Product Code: LJS
• UDI-Device Identifier: H965458760
• UDI-Public: H965458760
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 45876
• Device Lot Number: 5850085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: 65 YR
• Patient Sex: Female