MAUDE Adverse Event Report: VYGONGMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.203

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Cardiac Tamponade (2226); Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2023

Event Type  Injury  

Event Description

The central line was inserted on (b)(6) 2023.Following the radio control post installation, at the time of the installation, the way had been withdrawn of 2 cm (because located in the right atrium), made according to the usual procedure of the service.On (b)(6) 2023, following deterioration of the newborn, he had to be intubated because he presented a "prolonged low flow".At that moment, they discovered the cardiac tamponade : the child has low cardiac output as a result of the tamponade.That is, the tamponade caused an influx of air or fluid around the heart.This considerably reduces its size and the flow of the circulation is also reduced.The "noble" organs are no longer irrigated with a good blood flow.They receive less blood.

Manufacturer Narrative

The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 16529880
• MDR Text Key: 311236101
• Report Number: 2245270-2023-00018
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1261.203
• Device Lot Number: 290322GP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: No
• 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