EN SNARE® ENDOVASCULAR SNARE

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED FOR EVALUATION. PHOTOS OF THE COMPLAINT HAVE BEEN RECEIVED. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING THE IVC FILTER REMOVAL PROCEDURE, THE SNARE HAD DETACHED AND WAS REMOVED FROM THE PATIENT VIA ANOTHER SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.