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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC PORT A CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, INTRAVASCULAR
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ST PAUL DELTEC PORT A CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, INTRAVASCULAR Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problems Death (1802); Foreign Body In Patient (2687)
Event Date 04/01/2020
Event Type  Injury  
Event Description
Information was received indicating that a smiths medical deltec port a cath implantable access system was attempted to be removed but was unable to remove the entire catheter.Subsequently, a second surgery was performed to remove the remaining portion of the catheter.It was reported that the patient later expired.There were no further reported adverse effects.
 
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Brand Name
DELTEC PORT A CATH IMPLANTABLE ACCESS SYSTEM
Type of Device
PORT AND CATHETER, IMPLANTED, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10271041
MDR Text Key198720183
Report Number3012307300-2020-07271
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/17/2020
Initial Date FDA Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age40 YR
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