MAUDE Adverse Event Report: ANGIODYNAMICS, INC BIOFLO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	H965440220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer for evaluation.An investigation into the root cause for this event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An angiodynamics territory manager reported an issue with a bioflo 8f single plastic filled; valved.During a port placement procedure, the guidewire degloved inside the patient's subclavian and an additional procedure was needed for removal.Currently, the patient is stable and not experiencing any adverse effects.No further details could be obtained.
Additional Manufacturer Narrative
The customer's reported complaint description of guidewire (tip) detached inside patient cannot be confirmed.No guidewire sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A device history record review of the packaging/guidewire lots was performed and search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/guidewire lots for similar guidewire tip detached issue.This is the only reported complaint for this guidewire detached failure mode for the bioflo/xcela plus port product family in the past 15 months, as such, this is deemed to be an isolated incident.Labeling review: the direction for use (dfu) that is provided with this device contains the following statements: percutaneous procedure: straighten "j" tip of guidewire with tip straightener and insert tapered end of tip straightener into the needle.Pass j-tip guidewire through the needle and advance to the superior vena cava.Advance the guidewire as far as appropriate for the procedure.Verify correct positioning using fluoroscopy or other appropriate technology.Gently withdraw and remove the needle and secure the guidewire.Precaution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit to help prevent the needle from damaging or shearing the guidewire.Potential complications: catheter occlusion, malposition, dislodgement, fragmentation, migration, disconnection or rupture.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint continues to be monitored for trends.Reference (b)(4).

• Brand Name: BIOFLO
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 22102365
• Report Number: 1317056-2025-00138
• Device Sequence Number: 17922756
• Product Code: LJT
• UDI-Device Identifier: 15051684018746
• UDI-Public: 15051684018746
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153228
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H965440220
• Device Catalogue Number: 44022
• Device Lot Number: 5830584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Unknown
• Patient Weight: 99 KG