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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIO DYNAMICS DURAFLOW 2 HEMODIALYSIS CATHETER

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ANGIO DYNAMICS DURAFLOW 2 HEMODIALYSIS CATHETER Back to Search Results
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.
 
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Brand Name
DURAFLOW 2 HEMODIALYSIS CATHETER
Type of Device
DURAFLOW 2 HEMODIALYSIS CATHETER
Manufacturer (Section D)
ANGIO DYNAMICS
latham NY 12110
MDR Report Key6352589
MDR Text Key68230325
Report NumberMW5068034
Device Sequence Number1
Product Code MSD
Number of Events Reported1
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 NumberDURAFLOW 2 HEMODIALYSIS CATHETER
Device Catalogue Number10301203
Device Lot Number566484
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age44 YR
Patient Weight99
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