MAUDE Adverse Event Report: ST PAUL DELTEC

Model Number 21-4071-24

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Thrombosis (2100)

Event Date 07/06/2020

Event Type  Injury  

Event Description

Reported an adverse event occurred with a smiths medical implantable ports|deltec port-a-cath ii ports.The facility reported on july 2nd july 2020 per thier words."the patient was hospitalized for chemotherapy.After use the ports infused, the patient felt pain and swelled around the infusion port.7-6 lines of angiography showed that at the horizontal of the cervical root about the c5 vertebral body, a small amount of contrast agent exuded in a filamentous form, and the contrast agent could be seen entering the superior vena cava.Consider cracks in the pipeline of the infusion port.Deep vein thrombosis around the lumen of the patient requires anticoagulation therapy.This event is risky.If it is not discovered and handled in time, it may cause serious injury.".

• Brand Name: DELTEC
• 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: 11137341
• MDR Text Key: 225716666
• Report Number: 3012307300-2021-00213
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586017841
• UDI-Public: 10610586017841
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942024
• 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: 01/08/2021

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 Expiration Date: 11/04/2021
• Device Model Number: 21-4071-24
• Device Catalogue Number: 21-4071-24
• Device Lot Number: 3349912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR