HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

TO DATE, IT IS UNKNOWN IF THE PRODUCT IS AVAILABLE FOR RETURN AND EXAMINATION. 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 INCLUDING A 100% VISUAL INSPECTION. THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

DURING PREPARATION FOR SURGERY FOR AN AORTIC DISSECTION, A HAIR WAS FOUND INSIDE THE PRODUCT. THE CUSTOMER FINISHED THE OPERATION WITH ANOTHER AVAILABLE PRODUCT FROM SAME LOT.

Additional Manufacturer Narrative

(10/170) THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS INSPECTED BY THE QUALITY ASSURANCE (QA) MANAGER FOR EVALUATION. HIS OBSERVATIONS ARE AS FOLLOWS: "-THE BOX CAME WITH A TAMPER-EVIDENT LABEL CUT OFF. -THERE IS A MATCH BETWEEN THE PRODUCT, THE LABELING OF THE BOX AND THE PATIENT SET. THERE IS NO NOTICE IFU OR GRAFTSIZER. -THE PRODUCT SHOWS: A PURPLE STAIN AT ONE OF ITS ENDS ; THE PRESENCE OF 2 FIBERS OUTSIDE THE GRAFT. -REGARDING THE PURPLE STAIN, IT DOES NOT COME FROM OUR MANUFACTURING PROCESS. REGARDING THE FIBER, IT COULD BE A DARK FIBER FROM THE REFERENCE LINE, ATTACHED OR NOT TO IT, AND LOCATED OUTSIDE THE FABRIC OR A FOREIGN BODY. THE FIBER EXCEEDS A SURFACE AREA OF 0.03MM2 ACCORDING TO TAPPI CHART MES 19-037. THE "HAIR FOUND" INSIDE THE PRODUCT BY THE CUSTOMER WAS NOT FOUND. AS THE PRODUCT HAS BEEN MANIPULATED, IT IS NOT POSSIBLE TO KNOW IF THE FIBER WAS GENERATED DURING THE PROCESS. THE PRODUCT, AS IT WAS RECEIVED, IS NOT CONFORM DUE TO A FOREIGN MATTER FOUND ON THE GRAFT.". (4315) NO CONCLUSION CAN BE DRAWN. THE PRODUCT AS IT WAS RECEIVED DOES NOT CONFORM TO THE SPECIFICATION. HOWEVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. THE CAUSE OF THE EVENT REMAINS UNKNOWN SINCE THE GRAFT HAS BEEN MANIPULATED BY THE USER.