MAUDE Adverse Event Report: VYGON USA LEADERFLEX; INTRAVASCULAR CATHETER

Model Number 1212.08

Device Problems Separation Failure (2547); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

The failed sample is being 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 with fda within 30 days of completion.

Event Description

Wire got stuck in leaderflex catheter after placement.Could not be unstuck.

Event Description

Wire got stuck in leaderflex catheter after placement.Could not be unstuck.

Manufacturer Narrative

Correction: the contact office - manufacturing site should be vygon gmbh, prager ring 100 aachen 52070, gm.The previous initial report mdr-2245270-2021-00007 listed vygon, 5 rue adeline ecouen 95440, fr erroneously.We have received the catheter with the guidewire inside as faulty sample.After flushing the catheter with water (past the guidewire), it was possible to remove the guidewire.Microscopic examination shows that in the middle range of the guidewire are residues of plastic fibers which are responsible for the difficult removability of the guidewire.Furthermore, traces of blood are visible, even under the fibers.We took a sample of the sheet in which the catheter is wrapped and compared it with the fibers on the guidewire.These looks similar.The catheter is delivered with the guidewire inside it.Therefore, the user must remove the guidewire before introducing it according to the seldinger-technique.Obviously, the plastic fibers were not on the guidewire before catheter placement as the removing problems only occurred when the catheter was already inserted.In addition, blood traces were found under the plastic fibers as well which indicates that the fibers deposited only during the insertion process.A review of the batch history records was performed, and 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 with no exceptions found.There are two further complaints for batch 030919gh and no further complaints regarding guidewire removal problems on code 1212.08 within the last three years.Corrective action: no further corrective action initiated by quality management due to this complaint, as there are no indications of a manufacturing fault.

• Brand Name: LEADERFLEX
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 13518959
• MDR Text Key: 288182484
• Report Number: 2245270-2022-00007
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1212.08
• Device Catalogue Number: 1212.08
• Device Lot Number: 030919GH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• 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