MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO DURAMAX; BIOFLO DURAMAX WITH ENDEXO TECHNOLOGY CHRONIC HEMODIALYSIS CATHETER BASIC KIT

Model Number	02-804
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.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 with a bioflo duramax 15.5f 28cm dual valve sheath basic kit.During a dialysis treatment, an air leak (microbubbles) caused the alarm to go off.The catheter was tested by clamping the catheter and air was able to be aspirated in the arterial limb.Due to this, the dialysis treatment was stopped.The catheter was surgically replaced two days later under local anesthesia, and regular dialysis was resumed.
Additional Manufacturer Narrative
The customer's reported complaint description of during dialysis treatment the device was observed to have air drawn into the dialysis catheter cannot be confirmed, since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Device history record review of the packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/assembly lots for similar air bubbles issue.Potential root cause for this type of reported failure is a fracture of the extension tubing adjacent to the luer hub.Excessive torquing of this connection and/or not allowing cleaning agents to completely dry can be contributing factors for fracture of the extension tubing at this location.It is estimated this device was in situ for at least 10 months.Labeling review: the directions for use (dfu) that is supplied with the dialysis catheter device, contains the following statements: warnings in the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.Do not use acetone on any part of the catheter tubing.Exposure to this agent may cause catheter damage.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Examine catheter lumen and extensions before and after each treatment for damage.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: BIOFLO DURAMAX
• Common Device Name: BIOFLO DURAMAX WITH ENDEXO TECHNOLOGY CHRONIC HEMODIALYSIS CATHETER BASIC 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 12804
• MDR Report Key: 24058338
• Report Number: 1319211-2026-00003
• Device Sequence Number: 18515147
• Product Code: MSD
• UDI-Device Identifier: H965103028040
• UDI-Public: H965103028040
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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 Expiration Date: 01/31/2025
• Device Model Number: 02-804
• Device Lot Number: 5740715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• 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 Sex: Unknown