MAUDE Adverse Event Report: ANGIODYNAMICS DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	10302804
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A territory manager reported an end user experienced an issue when using a catheter from a duramax stacked tip 28cm str.Basic kit.It was reported the catheter's blue port had a slow flow and resistance.As it was indicated the device is available for return, it is reasonable to conclude the catheter was removed due to this issue.It is unknown if it was replaced.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
The reported 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).
Additional Manufacturer Narrative
Returned for evaluation was one (1) 28cm duramax dialysis catheter.There were no noted defects or damage observed during visual inspection; i.E.No kinks in the catheter or extension leg tubing.Functional testing was performed, no issues noteed.The device functioned as intended.The customer's reported complaint description of dialysis catheter tubing had occlusion/slow fluid flow could not be confirmed during evaluation of the returned complaint sample.Fluid flushed and aspirated with no issues, guidewire inserted with no issues and lumen width of tubing within specification.Device functioned as intended.The root cause for the customer experience with this device cannot be definitively determined.Potential root cause for this type of dialysis catheter failure mode is tip positioned against vasculature wall that impedes flow.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 provided with this product states: "a tunnel with a wide gentle arc lessens the risk of kinking.Irrigate catheter with saline, then clamp catheter extensions to assure that saline is not inadvertently drained from lumens.Use clamps provided.Caution: do not clamp the dual lumen portion of the catheter.Clamp only the extensions.Do not use serrated forceps, use only the in-line clamps provided.Insert the introducer needle with attached syringe into the target vein.Aspirate to insure proper placement".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: DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16273418
• Report Number: 1319211-2023-00003
• Device Sequence Number: 20696829
• Product Code: MSD
• UDI-Device Identifier: H787103028045
• UDI-Public: H787103028045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: 01/30/2024
• Device Catalogue Number: 10302804
• Device Lot Number: 5700953
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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