HEMASHIELD

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: (10/213) THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR BUT COULD FINALLY NOT BE INSPECTED INTERNALLY BY OUR QA SUPERVISOR DUE TO DETECTION OF A BIOCONTAMINATION RISK. THEREFORE, THE INVOLVED PROSTHESIS WAS SENT (AS RECEIVED) TO A QUALIFIED EXTERNAL LABORATORY FOR A VISUAL INSPECTION. THIS LABORATORY SENT THE ANALYSIS REPORT TO INTERVASCULAR ON (B)(6) 2020. THERE IS ONE MAJOR OBSERVATION NOTED: ¿TWO BLUE MARKS ARE OBSERVED ON BOTH SIDES OF EXTREMITY A OF SEGMENT 2. THEY WERE PROBABLY MADE USING A PEN FROM THE OPERATING ROOM. EXACTLY NEAR THOSE BLUE MARKS, TWO FOREIGN BODIES WERE MACROSCOPICALLY OBSERVED¿ AND THE CONCLUSION IS AS FOLLOWS: "THE MACROSCOPIC AND MICROSCOPIC ANALYSES OF THE PROSTHESIS REVEALS TWO FOREIGN BODIES CORRESPONDING TO MULTI-FILAMENTS OF TEXTILE FIBERS NEAR EXTREMITY A OF SEGMENT 2. IT HAS TO BE NOTICED THAT THIS EXTREMITY HAS BEEN CUT PROBABLY FOR IMPLANTATION PURPOSES AND A FIBER OF THE WOVEN STRUCTURE WAS DETACHING ITSELF." THIS ANALYSIS REPORT WAS FURTHER REVIEWED BY OUR QA MANAGER, WHO ASSUMED THAT THE FIBERS CAME FROM THE CUTTING OF THE PROSTHESIS AND ASKED FOR ADDITIONAL PICTURES IN ORDER TO BETTER SEE THE CUT PART OF THE PROSTHESIS. NEW PICTURES CONFIRMED THE FRAYING OF THE PROSTHESIS AT THE LEVEL OF THE CUTTING AREA. KNOWING THAT, IN ACCORDANCE WITH OUR INSPECTION PROCEDURE, PROSTHESES ARE 100% VISUALLY INSPECTED, EXTERNALLY AND INTERNALLY DURING MANUFACTURING, OUR QA MANAGER CONCLUDED THAT IT IS VERY LIKELY THAT THE FIBERS WERE DETACHED DURING THE CUTTING PERFORMED BY THE USER. (4109/213) CONSIDERING THE DEVICE EVALUATION CONCLUSION, A NEW REVIEW OF HISTORICAL DATA HAS BEEN PERFORMED. IT INDICATED THAT NO OTHER SIMILAR COMPLAINT (FRAYED GRAFT) WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. (61) BASED ON THE CURRENT AVAILABLE INFORMATION AND INVESTIGATION RESULTS, IT APPEARS THAT THE MOST PROBABLE EXPLANATION CONCERNING THE OCCURRENCE OF THIS EVENT IS THAT THE SUBSTANCES FOUND BY THE CUSTOMER ARE TEXTILE FIBERS COMING FROM THE GRAFT FRAYING, FOLLOWING THE USE OF A WRONG TOOL BY THE USER FOR CUTTING THE PROSTHESIS (STRAIGHT SCISSOR). THE BLUE PEN USED IN A SURGICAL PURPOSE FOR THE CUT OF THE PROSTHESIS COULD HAVE DONE A DARK COLOR TO THE FIBER, MAKING THINKING OF A HAIR. PLEASE NOTE THAT THE FOLLOWING MENTION IS PRESENT AS A PRECAUTION IN THE PRODUCT INSTRUCTIONS FOR USE: "WOVEN GRAFTS SHOULD BE CUT WITH A LOW TEMPERATURE, DISPOSABLE CAUTERY (E.G., ¿ 900°F/¿ 500°C) TO PREVENT RAVELING." IN CONCLUSION, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGEST THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING AND THE MOST PROBABLE ROOT CAUSE OF THE EVENT WOULD BE AN UNINTENDED USE ERROR. IN ACCORDANCE WITH OUR COMPLAINT HANDLING WORK INSTRUCTION, CUSTOMER WILL BE SPECIFICALLY INFORMED OF THIS IFU RECOMMENDATION, VIA THE COMPLAINT RESPONSE SENT TO THE CUSTOMER, IN ORDER TO PREVENT RECURRENCE OF THE USE ERROR. CORRECTED DATA: IN B5, MODIFICATION OF EVENT DESCRIPTION DUE TO ADDITIONAL INFORMATION. IN H6, FOLLOWING DEVICE EVALUATION, DEVICE CODE SET AS 2969 IN THE INITIAL MFR MDR IS REPLACED BY 1262.

Description of Event or Problem

SEE INITIAL MFR REPORT #1640201-2020-00021 (COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED ON DEC 15, 2020 AND DEC 16, 2020 CONCERNING THE EVENT: : "THERE IS ONLY SPECULATION THAT THE FOREIGN OBJECT MAY HAVE BEEN BLOWN AWAY SOMEWHERE BECAUSE IT IS A VERY FINE FOREIGN OBJECT." THE CUSTOMER USED "STRAIGHT SCISSOR". THE GRAFT WAS CUT FOR " IMPLANTATION PURPOSE." A BLUE PEN IS "USED FOR SUCH SURGERY TO MARK THE AREA TO BE CUT IN ADVANCE WITH A SURGICAL PEN."

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE IS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR. A VISUAL INSPECTION BY OUR QUALITY ASSURANCE (QA) SUPERVISOR IS ANTICIPATED BUT NOT YET PERFORMED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

DURING SURGERY PREPARATION FOR AN AORTIC DISSECTION, FOREIGN SUBSTANCES (A LITTLE LONGER THAN THE LENGTH OF THE EYELASHES) WERE FOUND IN THE GRAFT AND THE SURGEON STOPPED USING IT. THE SURGERY WAS COMPLETED WITH OTHER COMPANY'S PRODUCT OF THE SAME SIZE. THERE IS NO PATIENT EFFECT REPORTED AND THERE IS NO PATIENT INFORMATION. SURGERY WAS NOT DELAYED. UNFORTUNATELY, THE FOREIGN SUBSTANCES HAVE BEEN REMOVED BY THE CUSTOMER AND THERE IS NO PHOTO OF FOREIGN SUBSTANCES. THE SUBSTANCES ARE PRESUMED TO BE HAIR SLIGHTLY LONGER THAN THE SIZE OF THE EYELASHES. PRODUCT HAS BEEN RETURNED TO MANUFACTURER.