MAUDE Adverse Event Report: VYGON LEADER-CATH; INTRAVASCULAR CATHETE

Model Number 115.11

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

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

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

The failed sample will be returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of completion.The batch review of this batch shows that the product is compliant to its specification.The tensile strength is conform to iso norm.

Event Description

Back in september the leadercath broke away at the shoulder and necessitated a surgical procedure to remove the catheter from the patient artery.

Event Description

Back in september the leadercath broke away at the shoulder and necessitated a surgical procedure to remove the catheter from the patient artery.

Manufacturer Narrative

We did not receive a sample for investigation.We just received a picture of the hub.Without a sample, it is impossible to determine the root cause of this event.The visual examination of the picture shows that the catheter tube was broken from its hub.We can see a short part of the tube at the anti-kinking sleeve.The controls during the manufacturing process make it possible to ensure that the product was compliant.The tensile results during manufacturing were above the specification of 10n.In the ifu , a caution is as follows: « 11.Do not suture directly around the catheter as this will result in damage.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.» the batch review is in compliance with all specifications, no anomaly were detected.This event is not linked to a quality defect of this device but to the conditions of use.

• Brand Name: LEADER-CATH
• Type of Device: INTRAVASCULAR CATHETE
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen 95440 ; FR 95440
• MDR Report Key: 9473333
• MDR Text Key: 176783858
• Report Number: 2245270-2019-00080
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K813142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 115.11
• Device Catalogue Number: 115.11
• Device Lot Number: 070618EG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention