MAUDE Adverse Event Report: ANGIO DYNAMICS DURAFLOW 2 HEMODIALYSIS CATHETER

Model Number DURAFLOW 2 HEMODIALYSIS CATHETER

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

Pt had a tunneled ij hemodialysis catheter (placed on (b)(6) 2013).On (b)(6) 2017, the pt was scheduled to have it removed.Upon removal of the catheter, it was noted that the cuff was retained inside the pt.An expert physician was contacted for assistance.She was unable to locate the cuff and it was decided that attempting to locate/remove it would cause more harm than leaving it in.The pt was later discharged with info and instructions related to the retained cuff.This event did not result in prolonged hospitalization or injury to the pt.

• Brand Name: DURAFLOW 2 HEMODIALYSIS CATHETER
• Type of Device: DURAFLOW 2 HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIO DYNAMICS; latham NY 12110
• MDR Report Key: 6352589
• MDR Text Key: 68230325
• Report Number: MW5068034
• Device Sequence Number: 1
• Product Code: MSD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2017

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
• Device Operator: Health Professional
• Device Model Number: DURAFLOW 2 HEMODIALYSIS CATHETER
• Device Catalogue Number: 10301203
• Device Lot Number: 566484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 99