ATRIEVE VASCULAR SNARE KIT 7FR

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

Description of Event or Problem

ATRIEVE WAS USED TO REMOVE IVC FILTER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THEN WHEN THE ATRIEVE SNARE WAS REMOVED FROM THE PATIENT, THERE WERE SOME ADHERED SUBSTANCES COILED AROUND THE SHAFT. THE ADHERED SUBSTANCES LOOKS PARTIALLY FLUFFY. (B)(6) COMMENT: THE CUSTOMER WOULD LIKE TO KNOW WHAT THESE SUBSTANCES ARE. PLEASE KINDLY ADVICE US IF THESE ARE KNOWN PHENOMENON AND/OR WHAT POSSIBLY THESE ARE. BECAUSE THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM, NO CREDIT MEMO IS REQUESTED.

Additional Manufacturer Narrative

ONE SAMPLE WAS RETURNED FOR REVIEW, OUTSIDE OF ITS ORIGINAL PACKAGING. VISUAL INSPECTION OF THE SAMPLE DOES SHOW A DARK, THIN MATERIAL SPINDLED AROUND APPROXIMATELY 2 INCHES OF THE GUIDEWIRE. THE MATERIAL DOES NOT MOVE FREELY, AND CRUMBLES INTO PIECES WHEN STRESS IS APPLIED. AS THE MATERIAL WAS FIRST NOTICED AFTER THE PROCEDURE WAS COMPLETED, THIS ISSUE IS LIKELY TO HAVE OCCURRED DURING OR AFTER THE PROCEDURE IN THE USER'S ENVIRONMENT. THE COMPLAINT IS NOT CONFIRMED. AS NO MANUFACTURING DEFECT HAS BEEN DETECTED, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

ATRIEVE WAS USED TO REMOVE IVC FILTER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THEN WHEN THE ATRIEVE SNARE WAS REMOVED FROM THE PATIENT, THERE WERE SOME ADHERED SUBSTANCES COILED AROUND THE SHAFT. THE ADHERED SUBSTANCES LOOKS PARTIALLY FLUFFY. SUGAN COMMENT: THE CUSTOMER WOULD LIKE TO KNOW WHAT THESE SUBSTANCES ARE. PLEASE KINDLY ADVICE US IF THESE ARE KNOWN PHENOMENON AND/OR WHAT POSSIBLY THESE ARE. BECAUSE THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM, NO CREDIT MEMO IS REQUESTED.