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

Catalog Number UNKNOWN

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics distribution manager reported an issue with a bioflo duramax catheter.During a procedure, the catheter was leaking, reportedly from under the leur neck.Dialysis was immediately stopped.This resulted in blood loss and air aspiration.The catheter was repaired and the leur neck was replaced.The procedure was then resumed.There was no report of adverse event or patient harm by the end user.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

This report is being submitted to close out the record.Additional information shows that the incorrect product was previously reported.The correct product will be reported under the correct registration number.Reference (b)(4).

Event Description

This report is being submitted to close out the record.Additional information shows that the incorrect product was previously reported.The correct product will be reported under the correct registration number.

• Brand Name: DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11075860
• MDR Text Key: 224049337
• Report Number: 1319211-2020-00089
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K101843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR