MAUDE Adverse Event Report: VYGON UMBILICAL CATHETER

Model Number 1270.04

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

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/10/2024

Event Type  Death  

Event Description

Preterm of 25 weeks + 4 days , weight 520 gr.Born on 9th (b)(6) 2024 with intraventricular communication.Umbilical catheter inserted on (b)(6), position controlled by x-ray after its insertion.The position was correct.Deterioration in the clinical condition of the newborn, desaturation on (b)(6) 2024 at 9pm, 10pm and 11pm.And cardiac slowdown.Pericardial perfusion was discovered, resulting in cardiac tamponade.Pericardial puncture was decided.Infusion per umbilical has been stopped.A dose of adrenaline was given but did not accelerate heart rate.Pericardial puncture yielded 3 ml of serosanguinous fluid, which did not accelerate heart rate.Decision to perform 2nd puncture after echo control: removal of 1.2 ml of serosanguinous fluid, i.E.4.2 ml in total.Subsequently, 1 dose of atropine and 1 dose of adrenaline were administered, heart rate still stable.No changes in vital parameters.After multidisciplinary discussion : in view of the prolonged hypoxia and prolonged bradycardia, the extreme prematurity of the baby and the intraventricular communication as well as the expected severe cerebral lesions, the decision was made to stop resuscitation care.The newborn died on (b)(6) 2024 at 11:59 pm.The hospital states that during discussions with the physicians in the neonatal intensive care unit, this death could not be attributed to the device, as this child was extremely premature and in very poor condition of health.

Manufacturer Narrative

The batch review does not show any non-conformity.The products are in conformity with the specifications.The devices are compliant to norm (b)(4).All controls are compliant, including the 100% tests carried out on each catheter during the manufacturing process.These tests are as follows: the bluntness of the catheter tip , marking the catheters.And tightness.Pericardial effusions and cardiac tamponades are rare but wellknown complications associated with the placement of umbilical catheters.These complications are associated with the intracardiac position of the catheter when it is placed too far into the heart.According to the analyse of the physicians of this hospital, the death is attributed to the extremely premature newborn and to its very poor condition of health.It is highly unlikely that this incident was due to a defect of the catheter.From our historical analysis of complaints, these 3 last years on all umbilical catheter code 1270.Xx, there was no other occurrence of cardiac effusion or tamponade.Furthermore, there is no complaint and no other incident of the involved batch.

Event Description

Preterm of 25 weeks + 4 days , weight 520 gr.Born on (b)(6) 2024 with intraventricular communication.Umbilical catheter inserted on (b)(6), position controlled by x-ray after its insertion.The position was correct.Deterioration in the clinical condition of the newborn, desaturation on (b)(6) 2024 at 9pm, 10pm and 11pm.And cardiac slowdown.Pericardial perfusion was discovered, resulting in cardiac tamponade.Pericardial puncture was decided.Infusion per umbilical has been stopped.A dose of adrenaline was given but did not accelerate heart rate.Pericardial puncture yielded 3 ml of serosanguinous fluid, which did not accelerate heart rate.Decision to perform 2nd puncture after echo control: removal of 1.2 ml of serosanguinous fluid, i.E.4.2 ml in total.Subsequently, 1 dose of atropine and 1 dose of adrenaline were administered, heart rate still stable.No changes in vital parameters.After multidisciplinary discussion : in view of the prolonged hypoxia and prolonged bradycardia, the extreme prematurity of the baby and the intraventricular communication as well as the expected severe cerebral lesions, the decision was made to stop resuscitation care.The newborn died on (b)(6) 2024 at 11:59 pm.The hospital states that during discussions with the physicians in the neonatal intensive care unit, this death could not be attributed to the device, as this child was extremely premature and in very poor condition of health.

Manufacturer Narrative

We received the involved umbilical catheter.The visual examination did not shown any anomalies or defect on this umbilical catheter.No sign of obvious manufacturing material weakness, was identified during catheter examination.Furthermore, this umbilical catheter complies to its specifications, dimensions, marking, bluntness of its tip and tightness.According to the analyses of the physicians of this hospital, the death is attributed to the extremely premature newborn and to its very poor condition of health.It is highly unlikely that this incident was due to a defect of the catheter.The batch review does not show any non-conformity.The products are in conformity with the specifications.The devices are compliant to norm iso 10555-1.All controls are compliant, including the 100% tests carried out on each catheter during the manufacturing process.These tests are as follows: the bluntness of the catheter tip , marking the catheters.And tightness.Pericardial effusions and cardiac tamponades are rare but wellknown complications associated with the placement of umbilical catheters.These complications are associated with the intracardiac position of the catheter when it is placed too far into the heart.From our historical analysis of complaints, these 3 last years on all umbilical catheter code 1270.Xx, there was no other occurrence of cardiac effusion or tamponade.Furthermore, there is no complaint and no other incident of the involved batch.

• Brand Name: UMBILICAL CATHETER
• Type of Device: UMBILICAL 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 19446 ; 8004735414
• MDR Report Key: 18535181
• MDR Text Key: 333135476
• Report Number: 2245270-2024-00006
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K921352
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1270.04
• Device Lot Number: 311023PB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• 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): Death
• Patient Age: 1 DA
• Patient Weight: 1 KG