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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT CT SGL 9.6 FR; PORT-A-CATH (MEDIPORT)
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ANGIODYNAMICS SMART PORT CT SGL 9.6 FR; PORT-A-CATH (MEDIPORT) Back to Search Results
Model Number H787CT96STSD0
Device Problems Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem Embolism (1829)
Event Type  Injury  
Event Description
On (b)(6) 2015, the pt was noted to have a dislodged catheter that had broken off with the catheter floating in the right atrium as well as the right ventricle.On (b)(6) 2015, the pt consented to percutaneous extraction of the catheter and the left upper chest was prepped and draped in a sterile fashion.An approximately 2 cm transverse incision was made and the skin and subcutaneous tissue was divided.The port was identified and dissected free from the surrounding capsule and removed.There was only about a 5 cm part of the catheter that was left behind.The rest of it was dislodged which was removed through a left groin incision into the femoral vein.The pt was admitted to be observed after procedure.Reason for use: port placement for lung cancer.
 
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Brand Name
SMART PORT CT SGL 9.6 FR
Type of Device
PORT-A-CATH (MEDIPORT)
Manufacturer (Section D)
ANGIODYNAMICS
14 plaza dr
latham NY 12110
MDR Report Key4771639
MDR Text Key5787231
Report NumberMW5042688
Device Sequence Number1
Product Code LJT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH787CT96STSD0
Device Catalogue NumberH787CT96STSD0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight92
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