MAUDE Adverse Event Report: VYGON LEADERCATH; INTRAVASCULAR CATHETER

Model Number 115.090

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2021

Event Type  Injury  

Event Description

Arterial catheter placed in radial artery for arterial monitoring.On dressing change it was noticed that arterial catheter had broken just below wing.Required intervention by the vascular surgeon to remove separated part of catheter.Vygon subsidiary in ireland has questioned the customer and we received additional information on 16th november.Patient is fine with no adverse outcome.They say that they do not use any sharps when removing dressings.Catheter was in situ for approximately 24 hours.We received pictures from the user see enclosed.

Manufacturer Narrative

The failed device will be returned to vygon for evaluation and complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.From the images of the proximal portion of the catheter and from previous investigations , we are aware that the catheter's tube has been damaged.On the picture, we noticed the red hub with its green anti-kinking sleeve and a small part of catheter's tube.The catheter's fracture is just at approx.1mm above this sleeve.The batch review shows that the devices are compliant to the specifications.The tensile strength measures are all above the minimum value of iso 10555-1 value (5n).The historical data analysis of complaints on this batch does not show any complaints on this batch.This is the first one of (b)(4) units sold since (b)(6) 2021.

Event Description

Arterial catheter placed in radial artery for arterial monitorting.On dressing change it was noticed that arterial catheter had broken just below wing.Required intervention by the vascular surgeon to remove separated part of catheter.Vygon subsidary in ireland has questionned the customer and we received additionnal information on 16th november.Patient is fine with no adverse outcome.They say that they do not use any sharps when removing dressings.Catheter was in situ for approximately 24 hours.We received pictures from the user see enclosed.

Manufacturer Narrative

We received the involved arterial catheter in 2 parts.One is the catheter with its hub and anti-kinking sleeve.The visual examination shows that the rupture is located just at the level of the anti-kinking collar.The other part, is the catheter tube.We noticed a kinking at 1,7 cm from the rupture with signs of damage on that catheter surface.The cause of that damage could not be identified.No sign of obvious manufacturing material weakness was identified during the catheters' examination.The anti-kink collar was removed.The catheter fracture was identified at approx.6mm from the hub.On examination under a microscope, a rough and uneven fracture surface was identified on both catheter section.A thinned/stretched aspect of the fracture site was also noted.From previous investigations, we are aware that these characteristics are associated with the occurrence of kinking with a tensile fracture having occurred.We understand from the reporting and interview that the device had been in situ for 24 hours prior to the reported fracture which occurred during the dressing change.The root cause of this rupture is traced to the usage.Stress and flexion may have been placed on the catheter (for example, movement of an extension set, cleaning around the insertion site).One catheter from same batch returned by customer has been examined.It is compliant, there is no sign of kinking or other non-conformity.The batch review shows that the devices are compliant to the specifications.The tensile strength measures are all above the minimum value of iso 10555-1 value (5n).The historical data analysis of complaints and incidents shows that is no similar issue of catheter rupture on this batch.The cautions are described in the ifu, as follows: avoid kinking the catheter as this will damage the catheter tubing.As with all catheters, it is important to position and to ensure that they are not kinked or bent in any way which might stress the catheter material, or which might disturb the normal flow of fluids through the catheter.No further corrective action initiated by quality management due to this complaint, as there are no indications of a manufacturing fault.

• Brand Name: LEADERCATH
• Type of Device: INTRAVASCULAR 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 o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 13043604
• MDR Text Key: 283751014
• Report Number: 2245270-2021-00130
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K813142
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 115.090
• Device Catalogue Number: 115.090
• Device Lot Number: 220121EE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• 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): Required Intervention