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

Model Number 1261.207

Device Problems Positioning Failure (1158); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.

Event Description

Pericardial perfusion (tamponade) occurred 12 hours after catheter placement in the right upper limb.Cardiac arrest due to tamponade.External chest compressions, administration of 3 units of adrenaline and puncture of the pericardium were performed.The problem was resolved after 10 minutes with cardiac resuscitation and the withdrawal of this catheter by 1 to 2 cm.

Manufacturer Narrative

We received one catheter as a sample still assembled inside the 24 g cannula.It is not possible to flush the catheter due to several severe occlusions.The catheter had been shortened at 2 cm.After removing the catheter from the cannula, the catheter tube was thoroughly examined microscopically but no defect could be detected.A slight fibrin formation was visible at about 9.5 cm.Cardiac tamponade is a rare complication of piccs placed in neonates.One reason for failure is the catheter tip inserted too far into the neonate's heart.This obviously happened here as well as we got informed that after detecting a cardiac arrest due tamponade, cardiac resuscitation was performed and the withdrawal of the catheter by 1 to 2 cm.Furthermore, we warn in the product's ifu: "the using physician should be familiar with and undertake all standard precautions to avoid problems or complications associated with the introduction and use of central venous catheters.Complications associated with percutaneous catheter placement include vessel wall perforation, cardiac tamponade, hemorrhage, air embolism, catheter embolism, nerve lesions, infections, thrombosis.Precautions: the catheter tip must not be advanced into the heart (right atrium).The location of the catheter within the heart may cause cardiac tamponade, or cardiac arrhythmias.It is necessary to make checks of the catheter tip position at regular intervals throughout the usage of the catheter." it seems as if the users did not do the tip position checks at regular intervals.Having checked the batch history records, no deviations were found.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out.This is the very first complaint for batch 040221go and we have two further complaints regarding a cardiac tamponade on code 1261.207 within the last three years.This type of defect is included in the risk analysis and its occurrence rate, and the risk evaluation is acceptable.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.

Event Description

Pericardial perfusion (tamponade) occurred 12 hours after catheter placement in the right upper limb.Cardiac arrest due to tamponade.External chest compressions, administration of 3 units of adrenaline and puncture of the pericardium were performed.The problem was resolved after 10 minutes with cardiac resuscitation and the withdrawal of this catheter by 1 to 2 cm.

• 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 o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12568860
• MDR Text Key: 274505477
• Report Number: 2245270-2021-00109
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K954302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1261.207
• Device Lot Number: 040221GO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2021
• 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): Life Threatening; Required Intervention