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

Model Number 2184.00

Device Problem Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 05/05/2020

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

Preterm newborn patient, required administration of total parenteral nutrition by picc catheter, on tolerating oral route total parenteral nutrition is suspended and withdrawal of the picc catheter located in the left upper limb is ordered, at the time of withdrawal incomplete catheter is observed and by measure 14.5 cm remain inside the patient, urgent catheterization is scheduled for removal of the device the procedure was performed without complications, stable patient.

Manufacturer Narrative

This complaint is not confirmed.We just received the distal catheter fragment with a length of 14,2 cm.Microscopic examination showed typical signs for a pressure burst.The tear of the burst runs around and could therefore lead to the catheter being separated.No signs of occlusions were visible.The product's ifu regarding stylet problems states the following in regards to avoiding pressure bursts: ""caution: do not use small syringes (<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 handheld syringe.Subjecting the catheter to pressure above 1.2 bar can result in catheter rupture and embolism; 1.Do not use infusion equipment which can exceed the working pressure of 1,0bar max/760 mm hg.2.Bolus injections should be slow and must not exceed the maximum bolus pressure of 1,2bar/900 mm hg.; 3.Do not use syringes smaller than 10 cc.Smaller syringes generate higher pressures than larger ones." a review of the batch history records showed no deviations.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out.This is the very first complaint for the possibly batches 250319gg and 170419gg and the fifth regarding a snapped catheter on code 2184.00 within the last three years.No further corrective action initiated by quality management as there are no indications for a manufacturing fault.

Event Description

Preterm newborn patient, required administration of total parenteral nutrition by picc catheter, on tolerating oral route total parenteral nutrition is suspended and withdrawal of the picc catheter located in the left upper limb is ordered, at the time of withdrawal incomplete catheter is observed and by measure 14.5cm remain inside the patient, urgent catheterization is scheduled for removal of the device the procedure was performed without complications, stable patient.

• Brand Name: EPICUTANEO CAVA CATHETER
• Type of Device: LONG-TERM INTRAVASCULAR CATHETE
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• MDR Report Key: 10158840
• MDR Text Key: 195280524
• Report Number: 2245270-2020-00038
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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: 250319GG
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention