GELSOFT

Additional Manufacturer Narrative

(B)(4). A REVIEW OF MANUFACTURING AND QC RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO REQUIRED SPECIFICATION. POROSITY TEST RESULTS FOR THE WHOLE BATCH OF 10 WERE WELL BELOW MAXIMUM POROSITY LIMIT OF 96 ML/MIN. (B)(4). THE ROOT CAUSE OF THE EVENT WAS NOT IDENTIFIED FURTHER ACTION IS NOT PLANNED; HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

Description of Event or Problem

EVENT WAS REPORTED TO VASCUTEK ON 29-NOV-2017 AS FOLLOWS: BLOOD LEAKAGE FROM THE CRUTCH AREA: DURING THE IMPLANT OF THE GELSOFT BIFURCATE INTERMEDIATE GRAFT, BLOOD LEAKAGE OCCURRED FROM A PIN HOLE IN THE CRUTCH AREA. THE PIN HOLE WAS STITCHED. NO HEALTH CONSEQUENCE FOR PATIENT.