MAUDE Adverse Event Report: ST PAUL DELTEC

Model Number	21-4071-24
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• MDR Report Key: 11137341
• Report Number: 3012307300-2021-00213
• Device Sequence Number: 19400648
• Product Code: LJT
• UDI-Device Identifier: 10610586017841
• UDI-Public: 10610586017841
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• 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): 01/08/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/07/2021
• 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: 72 YR