MAUDE Adverse Event Report: ST PAUL DELTEC; PORT CATHETER

Model Number	21-4051-24
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Chest Pain (1776); Weakness (2145)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PORT CATHETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11202455
• Report Number: 3012307300-2021-00577
• Device Sequence Number: 11694233
• Product Code: LJT
• UDI-Device Identifier: 10610586023514
• UDI-Public: 10610586023514
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K830730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR