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

Model Number 1261.306

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Pleural Effusion (2010)

Event Type  Injury  

Manufacturer Narrative

The results of this investigation are still pending and will be communicated to fda with in thirty days of its conclusion via followup mdr.

Event Description

Catheter placed in cubital vein with ultrasound and safe fixation.After 12 h pleural effusion was formed.Pleurocentesis carried out and patient transferred to another hospital.Another pleurocentesis carried out there.At the moment patients outcome unknown.Patient outcome: catheter caused pleural effusion; pleurocentesis necessary; patient transferred to another hospital.

• Brand Name: PREMICATH
• 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: 7714013
• MDR Text Key: 114834845
• Report Number: 2245270-2018-00050
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1261.306
• Device Lot Number: 040315GJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention