MAUDE Adverse Event Report: VYGON GMBH EPICUTANEO CAVA CATHETER; LONG TERM INTRAVASCULAR CATHETER

Model Number 2184.00

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/05/2017

Event Type  Injury  

Manufacturer Narrative

The details of this event are being analyzed as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda with in thirty days of its conclusion via follow-up mdr.

Event Description

After 7 days in use the customer wanted to withdraw the catheter.During procedure the catheter snapped inside the vessel.The extracted extravascular part of the catheter was kept.The rest part of the catheter is still in the femoral vein.It will be removed when baby will gain in weight.The baby is under specialists control.

• Brand Name: EPICUTANEO CAVA CATHETER
• Type of Device: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 7163477
• MDR Text Key: 96333147
• Report Number: 2245270-2017-00065
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K897168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/03/2018

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: No Information
• Device Model Number: 2184.00
• Device Lot Number: 060115GE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 01/04/2018
• 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