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

Catalog Number	10302804
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of dialysis catheter clamp kinked the extension leg tubing was not confirmed since no complaint sample was returned.Without receiving the complaint sample for evaluation, a definitive root cause cannot be determined.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use state: "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).
Event or Problem Description
An end user experienced with a catheter from a duramax stacked tip 28cm str.Basic kit.When the patient presented for a dialysis treatment using the implanted catheter, the provider was unable to perform dialysis as the clamp kinked the catheter and dialysis was unable to be run.The patient had to return to the hospital to have the catheter replaced.Once replaced, the patient was able to return to the dialysis center and have the full treatment.The patient did not experience any adverse effects or harm due to this incident.

• 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: 17184930
• Report Number: 1319211-2023-00039
• Device Sequence Number: 6495467
• Product Code: MSD
• UDI-Device Identifier: H787103028045
• UDI-Public: H787103028045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 08/31/2025
• Device Catalogue Number: 10302804
• Device Lot Number: 5772651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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