HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. THESE TESTS INCLUDE A 100% VISUAL INSPECTION OF THE GRAFT USING A BACKLIT TABLE TO REVEAL THE PRESENCE OF ANY HOLES IN THE TEXTILE STRUCTURE. MOREOVER, THE REVIEW OF THE WATER PERMEABILITY TESTING RECORDS OF A PRODUCT COATED ON THE SAME DAY AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. ONE RETENTION SAMPLE FROM SAME PRODUCT FAMILY, SAME LOT AND COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE WAS VISUALLY INSPECTED BY A QC OPERATOR UNDER REAL WORKING CONDITIONS. NO ANOMALY WAS FOUND. THIS RETENTION SAMPLE ALSO UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT REMAINED IMPLANTED. HOWEVER, A NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO INVESTIGATE THE ROOT CAUSE AND TAKE APPROPRIATE CORRECTIVE ACTIONS IF NECESSARY.

Description of Event or Problem

DURING SURGERY, A HOLE WAS IDENTIFIED AT THE CROTCH OF THE BIFURCATED GRAFT. THE SURGEON SEWED THE GRAFT HOLE IN ORDER TO STOP THE BLEEDING. PATIENT WAS ENDANGERED BUT NOT INJURED.

Additional Manufacturer Narrative

THE CONCLUSION HAS BEEN AMENDED: (25) THE OUTCOME OF THE INVESTIGATION INDICATES THAT THIS IS AN ISOLATED CASE, PROBABLY DUE TO INSUFFICIENT SEWING AT THE CROTCH OF THE GRAFT. IT HAS BEEN DECIDED TO INCREASE AWARENESS OF ALL SEWING OPERATORS CONCERNING THE RISK OF INSUFFICIENT SEWING.