VENCLOSE MICRO INTRO KIT, 7CM
Received Nov 3, 2021 · Event occurred Oct 9, 2021
Report 1423395-2021-00058 · MDR key 12745336
Device
Generic name
Venclose Micro Intro Kit, 7cm
Manufacturer
Medline Industruies LpCatalog number
VC-ISH-6F7
Lot number
21GBK939
Product problems
- Difficult to Remove
- Material Twisted/Bent
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE GUIDEWIRE BECAME KNOTTED AND WAS CAUGHT IN THE VEIN. THE CASE WAS ABLE TO BE FINISHED WITH A GOOD OUTCOME FOR THE PATIENT. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE GUIDEWIRE BECAME KNOTTED AND WAS CAUGHT IN THE VEIN. THE CASE WAS ABLE TO BE FINISHED WITH A GOOD OUTCOME FOR THE PATIENT.