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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON LEADER-CATH; INTRAVASCULAR DIAGNOSTIC CATHETER,
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VYGON LEADER-CATH; INTRAVASCULAR DIAGNOSTIC CATHETER, Back to Search Results
Model Number 115.090
Device Problems Activation, Positioning or Separation Problem (2906); Device Operational Issue (2914)
Patient Problem No Code Available (3191)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
The device involved in this event will be returned to vggon for 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 via follow-up mdr.
 
Event Description
Insertion of arterial line to left dorsalis pedis artery with patient anaesthetised.Uneventful placement of guidewire through needle (1st pass) arterial line railroaded over guidewire (again unremarkable) guidewire removed and pressure monitoring line attached.No pressure wave trace noted, unable to aspirate blood.Pressure line was removed and part of the guidewire was seen in the lumen of the art line.Forceps used to remove the guidewire.Guidewire retained in 2 pieces.Art line was removed as it still not working.X ray ordered for left foot as examination of the 2 parts leaves me unsure if there is another part to the faulty guidewire.No harm to patient.
 
Event Description
Insertion of arterial line to left dorsalis pedis artery with patient anaesthetised.Uneventful placement of guidewire through needle (1st pass) arterial line railroaded over guidewire (again unremarkable) guidewire removed and pressure monitoring line attached.No pressure wave trace noted, unable to aspirate blood.Pressure line was removed and part of the guidewire was seen in the lumen of the art line.Forceps used to remove the guidewire.Guidewire retained in 2 pieces.Art line was removed as it still not working.X ray ordered for left foot as examination of the 2 parts leaves me unsure if there is another part to the faulty guidewire.No harm to patient.
 
Manufacturer Narrative
3 guidewires were returned.We notice that all of them have been damaged, see enclosed pictures.The visual examination shows one broken wire, one broken/kinked and splitted wire and one kinked.This is characteristic of a mechanical strong strength apply to the guidewire and of a pull back in the needle.These devices are packed with the guidewire inserted in the catheter, therefore such kind of defect cannot be a manufacturing defect.It occured after use.There is a 100% quality inspection during the insertion of the guidewire in the catheter.The review of the batch record shows no deviation or non conformity.In our ifu there is a caution « the guidewire should advance without resistance.If resistance is felt, do not persist, stop and withdraw both the needle and guidewire simultaneous.Never pull back or withdraw the guidewire through the needle as this could damage the guidewire on the needle bevel».The event is not linked to a device defect, it is due to its use.
 
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Brand Name
LEADER-CATH
Type of Device
INTRAVASCULAR DIAGNOSTIC CATHETER,
Manufacturer (Section D)
VYGON
5 rue adeline
ecouen, 95440
FR  95440
MDR Report Key7450475
MDR Text Key107095259
Report Number2245270-2018-00017
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K813142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/18/2018
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 Number115.090
Device Catalogue Number115.090
Device Lot Number021017EE
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2018
Initial Date FDA Received04/23/2018
Supplement Dates Manufacturer Received04/13/2018
Supplement Dates FDA Received07/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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