MAUDE Adverse Event Report: VYGON UMBILICA CATHETER

Model Number 1272.04

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Death (1802); Extravasation (1842); Renal Failure (2041)

Event Date 01/12/2020

Event Type  Death  

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

(b)(6) week gestation infant born on (b)(6).Umbilical venous catheter inserted on the day of birth.On (b)(6) referred from hospital to (b)(6) with an acute abdomen.Tpn extravasation diagnosed at (b)(6) secondary to liver and abdominal extravasation of tpn from umbilical venous catheter.Drained soon after admission to (b)(6) with surgical peritoneal drain.Umbilical catheter removed.This catheter stays 5 days in situ.Baby subsequently went on to develop intractable renal failure and necrotising enterocolitis with perforation needing laparotomy.Palliative care commenced and intensive care withdrawn on the (b)(6).Baby died on (b)(6) 2020.

Manufacturer Narrative

We have received the involved umbilical catheter.During the investigation, the returned device functioned normally, with no signs of leakage identified when flushing either lumen of the device.Unfortunately, we are unaware as to how the location of the device was confirmed after placement.The instructions for use (ifu) provided with the device advise: "control of positioning: always check the location of the catheter by radiography.For umbilical arterial catheterization, the catheter can be sited either in the high position between thoracic vertebrae t6 and t9 or the low position at l3 to l5 level though the higher position is associated with lower complication rates.For umbilical venous catheterization, the catheter tip should be placed beyond the ductus venosus in the central venous system (inferior vena cava)." the returned catheter is conform, there is no defect.On evaluation of our historical datas since 2017, we can confirm that we have not received any additional reports of a similar nature for this product.The root cause of this adverse event is not linked to the quality of our device.

Event Description

(b)(6) gestation infant born on (b)(6).Umbilical venous catheter inserted on the day of birth.On (b)(6) referred from hospital to (b)(6) with an acute abdomen.Tpn extravasation diagnosed at (b)(6) to liver and abdominal extravasation of tpn from umbilical venous catheter.Drained soon after admission to (b)(6) with surgical peritoneal drain.Umbilical catheter removed.This catheter stays 5 days in situ.Baby subsequently went on to develop intractable renal failure and necrotising enterocolitis with perforation needing laparotomy.Palliative care commenced and intensive care withdrawn on the (b)(6).Baby died on (b)(6) 2020.

• Brand Name: UMBILICA CATHETER
• Type of Device: UMBILICA CATHETER
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• Manufacturer (Section G): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, pa ; 4735414237
• MDR Report Key: 9720395
• MDR Text Key: 179783718
• Report Number: 2245270-2020-00008
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• PMA/PMN Number: K981630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1272.04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2020
• 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): Death
• Patient Age: 29 WK