MAUDE Adverse Event Report: VYGON LEADERCATH; INTRAVASCULAR CATHETER

Model Number 115.090

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

They placed this catheter to a child with no problem.The catheter was in place during 4 days.When they extracted the catheter the polyethylene part stayed in the femoral artery and they had to call surgeon to extract the part of catheter.With surgery, the rest was extracted.The child is well, there were no clinical consequences.

Manufacturer Narrative

We received a part of the involved arterial catheter.It is the part of the rest of catheter's tube with its hub and anti-kinking sleeve, connected to an extension line.The visual examination shows that the catheter's rupture is located at 2 mm from the anti-kinking collar.A suture is around the hub.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.3mm from the hub.On examination under a microscope, an even/smooth aspect of the fracture surface was identified on catheter's section.Sign of damage/cut was also noted on the anti-kinking sleeve.This even/smooth surface is characteristics of a damage/cut by a sharp instrument.From this investigation, the catheter has been unintended cut during the removal procedure, probably when suture has been cut.In addition, we understood from the reporting that the device had been in situ for 4 days prior to the reported fracture which occurred during the removal.This means that the catheter was functioning correctly until its removal.The root cause of this rupture is traced to the usage.It is not linked to a defect of the catheter.The cautions are described in the ifu as follows: "cautions 15.Pay particular attention when manipulating a sharp or pointed instrument (scissors, scalpel, needle, etc.) in the immediate vicinity of the catheter, to minimize the risk of damaging/cutting the catheter." and "removal procedure: remove the suture taking care not to cut the catheter." batch testing shows that the devices are compliant, and there are no anomalies or deviations.Historical data analysis of complaints and incidents for the last 3 years, shows that there is no other complaint or incident in this leadercath batch.The rupture is not linked to a catheter defect but to the usage of it.It has been unintended cut of the catheter during its removal.

• 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: 15564670
• MDR Text Key: 306384075
• Report Number: 2245270-2022-00101
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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: 231121EF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Date Manufacturer Received: 08/11/2022
• 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