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

Model Number 1261.306 

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2022

Event Type  Injury  

Event Description

A premicath with reference (b)(4) was inserted in a newborn (38 weeks + 5 days; 3445 gr; meconium aspiration syndrome).When the picc line was removed, it broke off and a piece of 8 cm of iv line remained in the patient's lower right leg, to about knee height.The doctor decided to leave the catheter fragment initially in the patient.The decision if the fragment has to be removed is still undecided respectively unclear.

Manufacturer Narrative

The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion via follow-up mdr.

• 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: 18852039
• MDR Text Key: 337071477
• Report Number: 2245270-2024-00024
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1261.306
• Device Lot Number: 171221GQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2024
• 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
• Patient Age: 9 MO
• Patient Weight: 4 KG