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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON GMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER
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VYGON GMBH PREMICATH; LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 1261.307
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 04/09/2020
Event Type  Injury  
Manufacturer Narrative
The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.
 
Event Description
On (b)(6) 2020 (13 days after catheter placement): the doctor prescribed the removal of the epicutaneo-cava catheter to the nurse.When performing the procedure, she could feel a certain resistance.The doctor was called; he tried to gradually remove the device to no avail.An x-ray check was then performed.In the absence of any solutions, the doctor took the decision to pull on the device.The emerging part of the device broke, leaving the remainder of the catheter inside the child's left arm.
 
Event Description
On (b)(6) 2020 (13 days after catheter placement): the doctor prescribed the removal of the epicutaneo-cava catheter to the nurse.When performing the procedure, she could feel a certain resistance.The doctor was called; he tried to gradually remove the device to no avail.An x-ray check was then performed.In the absence of any solutions, the doctor took the decision to pull on the device.The emerging part of the device broke, leaving the remainder of the catheter inside the child's left arm.
 
Manufacturer Narrative
We received one catheter as a sample which had snapped at 11,8 cm.To the best of our knowledge the distal fragment (if uncut 11,8 cm!) is still in the patient.Microscopic examination confirms a rough surface of the cross section which is typical for a catheter breakage due to high tensile force.Furthermore, several radial tears confirm that the catheter had been elongated a lot before it snapped.There are different reasons why it could be difficult to remove the catheter: it can be assumed that the catheter tube has grown together with the vein wall after the 15 days in use.Fibrin formation on the catheter surface may indicate a patient reaction but could not be detected on the examined and returned proximal, extracorporeal part of the catheter tube.A fusion of the catheter tube with the vessel wall can occur in very rare occasions and can have various reasons: allergic patient reaction to latex if latex gloves (even unpowdered ones) are worn during insertion.Allergic patient reaction to pur (in very rare occasions).Poor/unfavorable catheter placement, so that the intima is irritated by catheter movements.The presence of hospital bacteria (if the catheter fragment will be removed the catheter tip should be examined in a laboratory) - the catheter tip of the returned proximal part did not show any germs beside staphylococcus epidermis.Without having the distal catheter fragment no further analysis is possible.It is unexplainable why a premicath (1fr) and not an epicutaneo cava (2fr) was used in a child weighing 4.5 kg.Concerning tensile force, we have a warning outlined in the product's ifu: "caution: do not over stretch the catheter as it may rupture, causing a catheter embolism." having checked the batch history records, no deviations were found.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out.The tensile force of the catheter tube (involved batch) was 3,8 n - the specification according to iso 10555-1 requires 1,5 n.This is the very first complaint for batch 141019go and the 10th regarding a snapped catheter tube on code 1261.307 within the last three years.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.
 
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Brand Name
PREMICATH
Type of Device
LONG-TERM INTRAVASCULAR CATHETER
Manufacturer (Section D)
VYGON GMBH
prager ring 100
aachen, 52070
GM  52070
MDR Report Key10047682
MDR Text Key190698511
Report Number2245270-2020-00029
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
PMA/PMN Number
K041468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1261.307
Device Lot Number141019GO
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/24/2020
Initial Date FDA Received05/12/2020
Supplement Dates Manufacturer Received04/24/2020
Supplement Dates FDA Received07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 WK
Patient Weight5
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