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

Model Number 21-4483-24

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907); Separation Problem (4043)

Patient Problems Pain (1994); Ventricular Fibrillation (2130); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  Injury  

Event Description

Information received a smiths medical implantable ports|deltec power port-a-cath ii ports catheter tube has detached from the port.No further information.

Manufacturer Narrative

Other text: one unit and four pictures were returned for investigation.Visual inspection of the device showed that the catheter was connected but broken.The photos showed what looked like improper procedure being done while using the device.For this, the root cause of the issue was found to have taken place after the device left the manufacturing site.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.The product sample labels were undamaged.One unit and four pictures were returned for investigation.The returned sample was received in decontaminated conditions without its original packaging.The complainant returned unit was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The sample was received with the catheter connected but broken, no discrepancies are detected on assembly configuration, nor in the catheter tip.The sleeve was pushed in the direction of the port and remained held in this way while the catheter was pulled back in the opposite direction of the port.No discrepancies detected; catheter remains in port when sleeve is not pushed in direction of the port and catheter can be pulled back when sleeve is pushed and remained held in direction of the port.The sleeve was pulled to verify if the catheter could be easily detached; the outlet tube was moved to the top of the catheter and the outlet tube was compressed to prevent the catheter from coming out.No discrepancies detected; catheter remains in port after test.The most likely cause is that the damage occurred after the product left the facility or during its use.According ifu excessive slack may increase the possibility of kinking and catheter flexing which may cause catheter occlusion and/or fracture as well as potential complications associated with the insertion or use of any implanted device or indwelling catheter including but not limited to catheter disconnection, fracture, rupture or shearing.The complaint was confirmed.The root cause was not determined.After returned sample analysis, it was concluded that the reported failure is not manufacturing process related, therefore no corrective actions can be taken.

Event Description

Additional information reported that the detached catheter was detected during patient use (during infusion, during contrast study).Complaint form states medical intervention was necessary and patient issues were resolved.While using the port-a-cath chamber left pectoral, acute pain occurred.Further diagnostic in using contrast imaging revealed disconnection of the tube at the capsule.Until surgical removal, the patient had observed no further pain or arrhythmias.The product was successfully explanted from the patient and did explant require 2 surgeries.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Type of Device: PORT - CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• 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; minneapolis, MN 55442
• MDR Report Key: 12147919
• MDR Text Key: 260950248
• Report Number: 3012307300-2021-07110
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: 10610586032776
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-4483-24
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3894409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention