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

Model Number 2184.00

Device Problems Material Fragmentation (1261); Material Rupture (1546); Difficult to Advance (2920); Migration (4003)

Patient Problems Pneumothorax (2012); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/25/2021

Event Type  Injury  

Event Description

On insertion of epicutaneo cava catheter, insertion above right wrist, placement of catheter to 15 cm mark, then feeling of stop.Attempts to withdraw the catheter, but elastic resistance, then rupture of the catheter.When withdrawing the needle, the proximal part of the catheter is retrieved, but the distal end (length about 10 cm) cannot be retrieved as it is not outside.Perform an x-ray check showing the catheter in the right upper limb, ending at the level of the superior vena cava.No haemodynamic or respiratory destabilisation.Transfer by (b)(6) in neonatal resuscitation to (b)(6) for surgical management.On arrival at (b)(6) at 9.30 pm, a new x-ray shows intracardiac migration of the catheter.Echocardiography by a paediatric cardiologist confirms the intracardiac location of the catheter with one end in the inferior vena cava.Collegial decision for catheter treatment by the paediatric cardiology team in a semi-emergency.Clinical stability overnight apart from moderately increased oxygen demand (fio2 0.25), no arrhythmias.X-ray check on (b)(6) at 7:30 a.M.: catheter intracardial with one end in the inferior vena cava, complete pneumothorax on the left side which had to be intubated and drained.To recover the part of the catheter that they could not extract, they use a snare catheter inside the vein (like a lasso) which allows them to pull the catheter fragment and recover it.

Manufacturer Narrative

The failed device will be returned to vygon for evaluation, the details of the malfunction will be evaluation as part of the complaint investigation.The results of the investigation are still pending and will be communicated to fda within thirty days of its conclusion via follow-up mdr.

Manufacturer Narrative

The hospital refused to forward the catheter to the manufacturer for investigation.From the customer's description the catheter obviously was cut during the attempt to remove it by pulling it back through the introducer needle (comment from sales rep g.C.Dated 01.Feb.2022 19:19 h), although we warn in the product's ifu: "do not at any time withdraw the catheter back through the winged needle.This may cause puncture or embolisation of a portion of the catheter." having checked the batch history records, no deviations were found.The batch complied to its specification and was released.This is the second complaint for batch no.180621gg.We received 12 further complaints regarding a snapped/broken catheter on code 2184.00 within the last three years, but none of them were related to a manufacturing defect.No further corrective action was initiated by quality management as there are no indications ofr a manufacturing fault.

Event Description

On insertion of epicutaneo cava catheter, insertion above right wrist, placement of catheter to 15 cm mark, then feeling of stop.Attempts to withdraw the catheter, but elastic resistance, then rupture of the catheter.When withdrawing the needle, the proximal part of the catheter is retrieved, but the distal end (length about 10 cm) cannot be retrieved as it is not outside.Perform an x-ray check showing the catheter in the right upper limb, ending at the level of the superior vena cava.No haemodynamic or respiratory destabilisation.Transfer by samu in neonatal resuscitation to hfme for surgical management.On arrival at hfme at 9.30 pm, a new x-ray shows intracardiac migration of the catheter.Echocardiography by a paediatric cardiologist confirms the intracardiac location of the catheter with one end in the inferior vena cava.Collegial decision for catheter treatment by the paediatric cardiology team in a semi-emergency.Clinical stability overnight apart from moderately increased oxygen demand (fio2 0.25), no arrhythmias.X-ray check on 26.11.At 7:30 a.M.: catheter intracardial with one end in the inferior vena cava, complete pneumothorax on the left side which had to be intubated and drained.To recover the part of the catheter that they could not extract, they use a snare catheter inside the vein (like a lasso) which allows them to pull the catheter fragment and recover it.

• Brand Name: EPICUTANEO CAVA CATHETER
• 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: 13392049
• MDR Text Key: 289272124
• Report Number: 2245270-2022-00004
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K897168
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2184.00
• Device Lot Number: 180621GG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 1 KG