HEMASHIELD PLATINUM WOVEN STRAIGHT

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTING TO INTERVASCULAR THAT DURING SURGERY, THE SURGEON USED A HEMASHIELD PLATINUM WOVEN STRAIGHT. THE PRODUCT WAS IMPLANTED WITHOUT ANY PRIOR TRIMMING. WHILE SUTURING THE ANASTOMOSIS WITH PROLENE SUTURE, THE GRAFT BEGAN TO FRAY OR UNRAVEL. THE SURGEON CUT DOWN A LITTLE FURTHER ON THE GRAFT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS AND THE SURGERY WAS NOT DELAYED. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

(3331/213) NO SERIAL NUMBER COULD BE PROVIDED BY THE HOSPITAL, ONLY THE STERILIZATION LOT NUMBER WAS KNOWN (21G14). BASED ON THESE INFORMATION, 3 POTENTIAL PRODUCTS ARE SUSPECTED TO BE THE PRODUCT INVOLVED IN THE EVENT. THE DEVICE HISTORY RECORD REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE/PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED FOR THE 3 POTENTIAL PRODUCTS. (11/213) TWO RETENTION SAMPLES WERE SELECTED BASED ON THE SAME TEXTILE PARAMETER AS THE SUSPECTED PRODUCTS. A VISUAL INSPECTION HAS BEEN PERFORMED BY A QUALITY CONTROL TECHNICIAN ON THE EDGES OF THE TWO RETENTION SAMPLES. IT CONCLUDED THAT THE PRODUCTS ARE IN COMPLIANCE WITH THE SPECIFICATION. (4112/213) THE CASE WAS REVIEWED BY THE CORPORATE MEDICAL DEPARTMENT WHOSE ASSESSMENT IS BELOW: "THE EVENT DESCRIBED IN THIS COMPLAINT RECORD INVOLVES A HEMASHIELD 10 X 60 CM WOVEN GRAFT WHICH APPEARED TO LOOK INTACT AND UNDAMAGED AS IT WAS REMOVED FROM ITS PACKAGING, HOWEVER UPON SUTURING THE GRAFT WITH A 5-0 PROLENE, THE GRAFT BEGAN TO FRAY. THE GRAFT WAS TRIMMED USING SCISSORS AND THE ANASTOMOSIS WAS THEN SUCCESSFULLY CREATED. NO SERIOUS INJURY OR HARM WAS DONE TO THE PATIENT, AND NO FURTHER COMPLICATIONS WERE ENCOUNTERED. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE/PLANNED DEVIATION IN RELATION TO THE EVENT REPORTED. IN ADDITION, TWO RETENTION SAMPLES WERE SELECTED BASED ON THE TEXTILE PARAMETERS. A VISUAL INSPECTION WAS PERFORMED BY A QUALITY CONTROL TECHNICIAN ON THE EDGES OF THE TWO RETENTION SAMPLES. IT CONCLUDED THAT THE PRODUCTS FOLLOW THE SPECIFICATION. AS THERE HAVE BEEN FEW (11 CASES/PAST FIVE YEARS) PRIOR COMPLAINTS OF FRAYING AND NO NON-CONFORMANCE FOUND DURING TESTING AND VISUAL INSPECTION OF RETENTION SAMPLES, IT IS IMPOSSIBLE TO KNOW EXACTLY WHAT CAUSED THE FRAYING OF THE HEMASHIELD GRAFT DURING THIS PROCEDURE. UPON EACH SIMILAR COMPLAINT INVESTIGATION, OCCURRENCE RATE FOR "GRAFT FRAYING" WILL CONTINUE TO BE CALCULATED." (4110/213) THE ACTUAL OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS ON THE SAME MANUFACTURING LINE (HEMASHIELD) FOR THE PERIOD 1- DEC-2021 TO 30-NOV-2022. THE OCCURRENCE RATE WAS 0.00%, WHICH IS BELOW THE ANTICIPATED OCCURRENCE RATE (MAXIMUM) OF 0.01%. (4315) BASED ON THE INVESTIGATION FINDINGS, NO CONCLUSION CAN BE DRAWN ON THE EXACT CAUSE OF THE GRAFT FRAYING DURING THIS PROCEDURE. HOWEVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING.

Description of Event or Problem

COMPLAINT # (B)(4).