MAUDE Adverse Event Report: ANGIODYNAMICS DURAMAX CHRONIC HEMODIALYSIS CATHETER

Catalog Number 10302804

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, our distributor in (b)(4) reported that after approximately two to three dialysis sessions, the catheter was "without flow".The dialysis catheter was exchanged for another new from a different manufacturer.There was no report of patient harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date, the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.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.(b)(4).

• Brand Name: DURAMAX CHRONIC HEMODIALYSIS CATHETER
• Type of Device: CHRONIC HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4379741
• MDR Text Key: 5288815
• Report Number: 1319211-2014-00248
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K080400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 10302804
• Device Lot Number: 596904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1