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

Model Number 1261.203

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem Pleural Effusion (2010)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

This complaint is not confirmed.We received one catheter as a sample which had been put in a little container.The catheter had been taped with steristrips and the wing protected with a plaster.When flushing the catheter it did not show any leakage or other defect.A little fibrin coating could be detected at the 10 cm marking during microscopical examination.The container was lettered with both (b)(6) report no.So we do not know to which report the sample is belonging to.The batch history did not show any deviations.This is the first complaint received for batch no.110118gm and the second complaint about pleural effusion on code 1261.203 and code 1261.2xx within the last three years no similar reports were received about pericardial effusion.Pleural effusion is a well-known complication in cvc placement and is described as possible complication in literature and in the product's ifu.Obviously a malplaced catheter caused the pleural and pericardial effusion.We neither know how long the catheters were in situ before effusions were detected nor if a position control of the catheter tip had been carried on.A manufacturing fault could be excluded for this kind of complaint.

Event Description

On (b)(6) 2018 pleural effusion on preterm baby occured.A hole is suspected due to the catheter.Increase of respiratory distress.Withdrawal of the catheter and drainage of effusion.

• 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: 7817786
• MDR Text Key: 118270702
• Report Number: 2245270-2018-00057
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 1261.203
• Device Lot Number: 110118GM
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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