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

Model Number 2184.00

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Fistula (1862); Cardiac Tamponade (2226)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation are still pending,and will be communicated to fda within 30 days of its conclusion.

Event Description

Catheter was placed to administer tpn and dopamine.4 days after placement a cardiac tamponade occurred.It was necessary to make a pericardial window (pericardial fistula).

Manufacturer Narrative

We received one unshortened catheter as a sample which immediately could be flushed and worked well.The catheter tip is slightly yellowish and the edges a little bit uneven (see photos).These are two phenomena that the catheters do not show when they leave our production.We do not think that the tip has not been shortened as the length of the tip marking is within our specification.It would have been interesting to know what happened to the tip of the catheter and whether it was cleaned or inserted into liquid.Obviously of bad positioning/movement of the catheter into the patient heart causes cardiac tamponade.In the product's ifu we warn: ""check correct positioning according to the local recommendations prior to commencing an infusion."" and we warn: ""complications associated with percutaneous catheters include vessel wall perforation, cardiac tamponade, haemorrhage, pleural and mediastinal injury, air embolism, catheter embolism, thoracic duct injury, septicaemia, bacteraemia, thrombosis, and accidental arterial puncture."" the catheter had been used for 4 days before problems occured.Up to today we are not aware of any information concerning the patients condition and more detailed information regarding catheter placement and positioning control although this event happened on (b)(6).Having checked the batch history records, no abnormalities were found.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out.This is the second complaint for batch (b)(4) and the second regarding a cardiac tamponade on code 2184.00 within the last 15 years.No further corrective action initiated by quality management as no fault could be detected.".

Event Description

Catheter was placed to administer tpn and dopamine.4 days after placement a cardiac tamponade occurred.It was necessary to make a pericardial window (pericardial fistula).

• Brand Name: EPICUTANEO CAVA CATHETER
• Type of Device: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• MDR Report Key: 8680205
• MDR Text Key: 147382274
• Report Number: 2245270-2019-00035
• 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
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

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: 240518GG
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention