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

Model Number 2184.00

Device Problem Material Fragmentation (1261)

Patient Problems Edema (1820); Swelling (2091); Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2018

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 follow-up mdr.

Event Description

Due to an edema to the forearm, an epicutaneo-cava-catheter was removed from the upper limb without any difficulty, but only 11 cm were removed.Nineteen (19) cm stayed in the patient and had to be removed surgically.

Manufacturer Narrative

This complaint cannot be classified, as no faulty sample was returned for analysis.Having checked the batch history records, no abnormalities were found.This is the second complaint received for batch 030317gg, the 15th complaint for a snapped catheter tube and the second regarding oedema on code 2184.00 within the last 3 years, but none of them were manufacturing related.It is essential to follow the porduct's ifu not to overstretch the catheter or to exceed the maximum pressure.In the product's ifu we warn: ""do not use syringes smaller than 10ml, as these can generate very high pressures.It is possible to generate 4 or 5 times the maximum safety pressure, with any size of hand held syringe.Subjecting the catheter to pressure above 17,4 psi can result in catheter rupture and embolism.Smaller syringes generate higher pressures than larger ones.The catheter can be used with a maximum bolus pressure of 1,2 bar.We strongly recommend to retrain the user in epicutaneo-cava-catheter handling.Without the sample no further analysis is possible.

Event Description

Due to an edema to the forearm, an epicutaneo-cava-catheter was removed from the upper limb without any difficulty, but only 11 cm were removed.19 cm stayed in the patient and had to be removed surgically.

• 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: 7357539
• MDR Text Key: 103037505
• Report Number: 2245270-2018-00011
• 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
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2184.00
• Device Catalogue Number: 2184.00
• Device Lot Number: 030317GG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention