MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH IMPLANTABLE VENOUS ACCESS SYSTE; PORT A CATH

Model Number	21-4023-24
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical implantable ports|deltec port-a-cath ports catheter was internally torn at connection piece between port chamber and catheter.Catheter placed in 2003.The catheter had not been used for years, only flushing every 3 months.No blood could be aspirated during the last flushing attempt by the home nurse.The gate was re-pierced several times at home, still in1as3.Made an appointment with the patient in the hospital to look at the functional problem.Port catheter was punctured with a 15mm huber point needle, smooth puncture, in1as3.However, upon infusion swelling is visible above the port.Catheter was removed on (b)(6) 2021, internally torn at connection piece between port chamber and catheter.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One used portal was returned with a section of catheter over the outlet tube and an unattached length of catheter measuring approximately 9.25 inches in length.Visual observation using the unaided eye as well as 5 times to 20 times microscopy found the catheter had multiple longitudinal slits where it had been connected to the portal at the maximum diameter of the outlet tube bulb.These visual characteristics are consistent with the catheter having been able to move relative to the port body.When the catheter bends at the outlet tube a crease can form in the catheter material.If this occurs often enough a crack or multiple cracks can form.The root cause related to the device was implanted 18 years ago.It was subjected to degradation and possible repeated movement over a long period of time resulting in the condition it was returned.

• Brand Name: DELTEC PORT-A-CATH IMPLANTABLE VENOUS ACCESS SYSTE
• Common Device Name: PORT A CATH
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; herestraat 49; minneapolis, MN 55442
• MDR Report Key: 12314478
• Report Number: 3012307300-2021-07514
• Device Sequence Number: 3620973
• Product Code: LJT
• UDI-Device Identifier: 10610586023781
• UDI-Public: 10610586023781
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K830730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2008
• Device Model Number: 21-4023-24
• Device Catalogue Number: 21-4023-24
• Device Lot Number: 98758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown