MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH II PORTS; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number	21-4083-24
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that on (b)(6) 2018, the ?seat" was buried in the chest wall, and on (b)(6) 23, 2023, the patient reported that he was ?unwell".The connection between the catheter and the port seat was found to be broken in the emergency department.The broken end of the catheter slipped to the brachiocephalic vein, and the tip fell to the heart position.The ruptured catheter was removed by interventional vena cava foreign body removal in the interventional department.
Additional Manufacturer Narrative
Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One used ?portal? was received with a section of catheter over the outlet tube and an unattached length of catheter measuring approximately 8 1/2 inches in length.Visual inspection found the catheter had broken away from itself where it had been connected to the ?portal?.The surface of the break itself is rough in appearance with multiple slits/cracking and was located at the maximum diameter of the outlet tube.Unknow exactly what forces the catheter had been subjected to or how and could be related to patient system placement or patient anatomy.This ?pac? system was manufactured in august 2016, was implanted in december 2018, and removed in may 2023.Shelf life is 5 years, device was implanted for 7 years.The complaint was confirmed, and a root cause could not be identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken.

• Brand Name: DELTEC PORT-A-CATH II PORTS
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17092396
• Report Number: 3012307300-2023-06116
• Device Sequence Number: 12279276
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• 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,Followup
• Report Date (Section B): 10/30/2023

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: 12/01/2020
• Device Model Number: 21-4083-24
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 3265745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2016
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 65 KG