SINGLE-LOOP SNARE RETRIEVAL KIT
Received Jan 18, 2022 · Event occurred Jan 10, 2022
Report 0001625425-2022-00931 · MDR key 13280433
Device
Generic name
Retrieval Kit
Manufacturer
Argon Medical DevicesModel number
380911120Catalog number
380911120
Product problems
- Material Fragmentation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SAMPLE IS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
AFTER THEY SNARED THE FILTER WITH THE RETRIEVAL KIT SNARE, THE DOCTOR SINCHED THE FILTER INTO THE 9FR SHEATH. THE DOCTOR THEN SHEATHED DOWN OVER THE FILTER WITH THE 11FR SHEATH AND RETRIEVED THE FILTER. THEN THE DOCTOR PUSHED SOME CONTRAST IN THE 11FR SHEATH FOR A FINAL CAVAGRAM, AND IT LOOKED GOOD. THEN WHEN HE PULLED THE 11FR SHEATH OUT IT HAD A STRING OF THE INNER SHEATH ATTACHED TO THE END OF THE 11FR SHEATH. IT WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT.