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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON USA LEADERFLEX; INTRAVASCULAS CATHETER
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VYGON USA LEADERFLEX; INTRAVASCULAS CATHETER Back to Search Results
Model Number VYLF1020
Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 06/20/2020
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
The line was being removed as per protocol and significant resistance was felt.The line had to be cut and a portion of the line was retained by the patient.The retained line was felt to be extracardiac and left inside the patient.
 
Manufacturer Narrative
We received one catheter as a sample.The catheter tube snapped at approx.8,7 cm distal the wing.The account should be aware that if the catheter was not shortened prior insertion, approx.11,3 cm are missing and may remain in patient.Microscopic examination of the fracture plane showed the typical rough surface for a tensile fracture.Furthermore, the breakage area is widened and has an oval shape - both signs for elongation before breakage.A review of the batch history records showed no deviations.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Incoming goods inspections and two 100% visual tests are performed after product is packaged.The tensile force for the involved catheter tubes was between 9,7 n and 13,1 n and therefore within our specification (min.3 n).This is the first complaint for code 4g07121220.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.Corrective action: based on the investigation, there are no indications for a manufacturing fault.Therefore, no corrective action will be initiated at this time.This failure will be monitored for future actions.
 
Event Description
The line was being removed as per protocol and significant resistance was felt.The line had to be cut and a portion of the line was retained by the patient.The retained line was felt to be extracardiac and left inside the patient.
 
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Brand Name
LEADERFLEX
Type of Device
INTRAVASCULAS CATHETER
Manufacturer (Section D)
VYGON USA
2750 morris road
lansdale PA 19446
MDR Report Key10656215
MDR Text Key210653749
Report Number2245270-2020-00089
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
) K141026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVYLF1020
Device Lot Number18F033D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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