ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
|
Back to Search Results |
|
Catalog Number 21-4483-24 |
Device Problems
Detachment of Device or Device Component (2907); Separation Problem (4043)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
Other text: b3: date of event is unknown, no information has been provided to date.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
|
|
Event Description
|
It was reported that a patient had a port a cath placed on (b)(6) 2019.On (b)(6) 2023 a chest x-ray was completed due to device difficulties which noted "right sided mediport catheter is noted".The tube has separated from the port and migrated approximately 5 cm.The tip was now in the region of the cavoatrial junction were previously it was overlying the svc.Vascular surgery consult was recommended, patient transferred to the ed where the surgeon removed the device bedside.Adverse patient effects are unknown.
|
|
Search Alerts/Recalls
|
|
|