MAUDE Adverse Event Report: ST PAUL DELTEC; PORT CATHETER

Model Number 21-4051-24

Device Problems Peeled/Delaminated (1454); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Chest Pain (1776); Weakness (2145)

Event Date 09/08/2020

Event Type  Injury  

Event Description

Information received a smiths medical implantable ports|deltec port-a-cath ii ports was implanted on the right side of jugular vein, subclavian vein, or superior vena cava.Not specified.Which vein.A patient was experiencing general malaise, cough and chest agitation, so an x-ray was performed and the doctor indicted the catheter should be taken out and placed on the left side.Upon surgical intervention to remove the catheter, is was reported not successful and the catheter was broken off 10-12 cm from the port without a visible stump for extraction.Reported on (b)(6) 2020 catheter was extracted by intervention radiology.The complaint talked about patient suffering from hiccups on going and being treated with metocloporamide.Unknown patient status at this time.

• Brand Name: DELTEC
• Type of Device: PORT CATHETER
• 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 Key: 11202455
• MDR Text Key: 227787843
• Report Number: 3012307300-2021-00577
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023514
• UDI-Public: 10610586023514
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K830730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 21-4051-24
• Device Catalogue Number: 21-4051-24
• Device Lot Number: 3862378
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR