MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	02-804
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2024
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 catheter from a bioflo duramax 15.5f 28cm dual valve sheath basic kit.The customer reports the duramax catheter was implanted (b)(6) 2024.For three months after insertion, the suture wing was sutured to the patient.Hoever, ast the time of the event it was not.On (b)(6) 2024 while ongoing hemodialysis the patient accidentally pulled out his catheter without much strength.Fortunately the dialysis machine stopped immediately.The line was not replaced.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
Received one (1) bioflo duramax dialysis catheter.As received, the device still had blood in the lumens and all were clamped.Could not remove the coagulated blood inside.The suture wing appeared to be within specification and the suture holes did not have any slices in them where a suture would slip through and not hold.The customer's reported complaint description of dialysis catheter was pulled out by the patient could not be confirmed given the patient centric nature of this event.Evaluation of the dialysis catheter sample returned did not observe any manufacturing non-conformance or damage to the suture wing.See below for summary and attached memo with engineer evaluation.The likely root cause for this event is patient error in pulling catheter out.It was also reported that the suture wing was not sutured to the patient at the time of this event.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use (16650701-01), which is supplied to the end user with this bioflo dialysis catheter device contains the following statements: catheter securement and securement dressing: 37.Suture insertion site closed.Suture the catheter to the skin using the suture wing.Do not suture through any part of the catheter.If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter.Contraindications: local tissue factors that will prevent proper device stabilization and/or access.Warnings: use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.The catheter should be used with caution and only after careful consideration in patients who are at risk of bleeding complications.Precautions: do not suture through any part of the catheter.If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter.Catheter tubing can tear when subjected to excessive force or rough edges.Avoid sharp or acute angles during implantation which could compromise catheter functionality.Adverse events/potential complications: exsanguination, hemorrhage.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
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21079925
• Report Number: 1317056-2025-00001
• Device Sequence Number: 8498006
• 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 Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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 Expiration Date: 04/30/2026
• Device Model Number: 02-804
• Device Lot Number: 5800451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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