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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS
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ST PAUL DELTEC; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS Back to Search Results
Model Number 21-4590-24
Medical Device Problem Codes Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes Pain (1994); No Consequences Or Impact To Patient (2199)
Date of Event 01/11/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the port was implanted in 2016, and after 5 years the catheter tear off.Urgent cath lab operation required.Access point right subclavian vein, under ultrasound, distal to clavicle.Patient felt pain at port when flushing - no reflux.Removed under local anesthesia.Cut over previous cut, port removed.Preliminary rtg pc done and observed catheter in the heart.Applicable attributes updated.Patient information updated.Catheter also already removed by interventional radiologist.
 
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Brand Name
DELTEC
Common Device Name
PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11364585
Report Number3012307300-2021-01459
Device Sequence Number4038060
Product Code LJT
UDI-Device Identifier10610586021541
UDI-Public10610586021541
Combination Product (Y/N)N
Initial Reporter CountrySI
PMA/510(K) Number
K961580
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/23/2021
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? No
Operator of Device No Information
Device Expiration Date01/01/2020
Device Model Number21-4590-24
Device Catalogue Number21-4590-24
Device Lot Number2886277
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2020
Initial Report FDA Received Date02/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age53 YR
Patient Weight60
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