MAUDE Adverse Event Report: PFM MEDICAL CPP SA TITA JET LIGHT LOW PROFILE; PORT

Model Number 61.636.09.070-K

Device Problem Material Separation (1562)

Patient Problem Foreign Body Embolism (4439)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Device history record was reviewed and the records are complete and in order.There were no non-conformances or capas associated with this issue.5 complaints are recorded for this type of issue.Based on record review and no returned product to evaluate, the root cause cannot be established.

Event Description

The system was implanted on (b)(6) 2019 in a 2 year old child in a private clinic.On (b)(6) 2020 the child was in a bad condition.In the hospital an x-ray was taken and it was found that the distal end of the catheter was detached.On (b)(6) 2020 anangiocardiography was performed.Foregn bodies were removed from the heart and vessels as well as the port chamber and click connector for the pocket.The child is better now.The removed material has been disposed of.

• Brand Name: TITA JET LIGHT LOW PROFILE
• Type of Device: PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA; all. du quartz 9; 2300 la chaux-de-fonds ; SZ
• Manufacturer (Section G): PFM MEDICAL CPP SA; all. du quartz 9; 2300 la chaux-de-fonds ; SZ
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 16112860
• MDR Text Key: 306819042
• Report Number: 3008737795-2023-00004
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: NOT FOR USA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 61.636.09.070-K
• Device Catalogue Number: 61.636.09.070-K
• Device Lot Number: 143111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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: 2 YR