EN SNARE®

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING AN IVC FILTER REMOVAL, THE PROVIDER NOTICED THAT THE IVC FILTER WAS TILTED. THE PHYSICIAN INSERTED A SNARE TO THE VENOUS ACCESS TO REMOVE THE IVC FILTER; HOWEVER, THE SNARE BROKE OFF AND WAS LEFT INSIDE THE PATIENT'S BODY. THE PHYSICIAN ATTEMPTED TO REMOVE IT, BUT THE CATHETER BEING USED BROKE OFF AND WAS LEFT IN THE PATIENT'S BODY AS WELL. BOTH THE CATHETER AND THE SNARE AND THE IVC FILTER WERE SUCCESSFULLY REMOVED AFTER AN EXTENDED PROCEDURE. NO EVIDENCE OF HARM PRESENT POST PROCEDURE, VITAL SIGNS WERE STABLE, AND THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL FOR OBSERVATION.