HEMASHIELD PLATINUM

Description of Event or Problem

COMPLAINT # (B)(4).

Additional Manufacturer Narrative

CORRECTED DATA: ON BLOCK H6, THE HEALTH EFFECT IMPACT CODE "2199" WAS UPDATED TO "4630" AND "4632". DUE TO THE LIMITED INFORMATION AVAILABLE ABOUT THE EVENT, A WORST-CASE SCENARIO APPROACH WAS APPLIED. ON BLOCK D6, LOT #."UNKNOWN", ON BLOCK D8, EXP. DATE "UNKNOWN", ON BLOCK E1, HEALTH PROFESSIONAL? "UNKNOWN", ON BLOCK E4, INITIAL REPORTER "UNKNOWN", ON BLOCK E9, EVENT SITE CITY "UNKNOWN", ON BLOCK E15, EVENT SITE EMAIL "UNKNOWN", ON BLOCK H4, MANUFACTURE DATE "UNKNOWN". ADDTL MFG NARRATIVE: (4117) THE DEVICE IS NOT ACCESSIBLE FOR TESTING, THEREFORE NO ANALYSIS COULD BE PERFORMED. (4111/3221) ON 11 MARCH, FOLLOWING A REQUEST TO ARRANGE A CALL WITH THE REPORTING PHYSICIAN, AND BASED ON CLARIFICATION RECEIVED THROUGH COMMUNICATION WITH GETINGE SALES REPRESENTATIVE, A REVIEW OF THE RECORD IDENTIFIED A DISCREPANCY IN THE RECORDED INFORMATION. IT WAS DETERMINED THAT A MIX UP HAD OCCURRED BETWEEN TWO SEPARATE RECORDS, IMPACTING: THE PHYSICIAN¿S NAME AND CONTACT DETAILS. THE LOT NUMBER OF THE INVOLVED PRODUCT. THIS TRIGGERED A THOROUGH VERIFICATION OF THE COMPLAINT RECORD INFORMATION AND AUDIT TRAIL BY THE DESIGNATED COMPLAINT UNIT TEAM MEMBER ASSIGNED WITH THE COMPLAINT TO IDENTIFY ALL POTENTIAL INCORRECT INFORMATION. THE REVIEW CONFIRMED THAT THE INFORMATION HAD BEEN INCORRECTLY ATTRIBUTED DUE TO A RECORD OVERLAP. AT THE TIME OF RECONCILIATION, THE CORRECT PHYSICIAN CONTACT DETAILS AND THE ACCURATE LOT NUMBER REMAINS UNKNOWN AS NO INFORMATION WAS PROVIDED BY THE PERSON WHO FILED THE COMPLAINT DESPITE GOOD FAITH EFFORTS (GFES). (4109) THE REVIEW OF HISTORICAL DATA INDICATED THAT ANOTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24G25. TO BE NOTED THE LOT NUMBER PROVIDED CORRESPONDS TO AN INTERGARD LOT, WHILE THE PRODUCT REFERENCE CORRESPONDS TO A HEMASHIELD PRODUCTS AND NO SERIAL NUMBER WAS PROVIDED. DESPITE OUR ATTEMPTS TO OBTAIN THE CLARIFICATION, NO FURTHER INFORMATION WAS PROVIDED. (3331/213) AS THE SERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER, THE DHR ANALYSIS WAS ONLY CARRIED OUT ON LOT NUMBER 24G25. NO DISCREPANCIES WERE OBSERVED IN RELATION TO THE REPORTED EVENT. (4112/3221) ALL THE AVAILABLE INFORMATION ON THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT, LEADING TO THE FOLLOWING CONCLUSION: THIS IS A COMPLAINT REGARDING A HEMASHIELD PLATINUM WOVEN STRAIGHT GRAFT IMPLANTED IN (B)(6) CHINA ON (B)(6) 2025. IT WAS REPORTED THAT A HOLE WAS OBSERVED THROUGH WHICH THERE WAS BLEEDING. REQUESTS FOR ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. CONSIDERING THE LIMITED AMOUNT OF INFORMATION PROVIDED IT IS DIFFICULT TO UNDERSTAND IF THERE WERE ISSUES WITH THE GRAFT, THE PROCEDURE OR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN, NO CONCLUSION CAN BE DRAWN ON THE EXACT ORIGIN OF THE EVENT. (4110/213) OCCURRENCE OF BLEEDING EVENTS ARE REVIEWED MONTHLY DURING QUALITY MEETING. IN (B)(6) 2026, THE BLEEDING EVENTS RATES ON HEMASHIELD AND INTERGARD PRODUCTS WERE WITHIN THE MAXIMUM ANTICIPATED BY THE PRODUCT RISK ASSESSMENT. (4315) DUE TO LIMITED AMOUNT OF INFORMATION, NO CONCLUSION CAN BE DRAWN ON THE EXACT ORIGIN OF THE EVENT. THERE IS NO IMPACT TO THE CONCLUSIONS PROVIDED IN MDR 1640201-2026-0000002 FU1.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT ON (B)(6) 2025, DURING A TRIAL RUN BEFORE USING THE ARTIFICIAL BLOOD VESSEL, A HOLE WAS DISCOVERED, CAUSING BLEEDING. THE LEAKING PORTION WAS SUBSEQUENTLY REMOVED. PATIENT INFORMATION COULD NOT BE TRACED.

Additional Manufacturer Narrative

(4118/3233) BASED ON THE INITIAL INFORMATION, THE INVOLVED GRAFT REMAINED IMPLANTED. THE FRAGMENT WITH SUSPECTED HOLES WAS REMOVED, AND IT IS YET TO BE CONFIRMED WHETHER IT WILL BE AVAILABLE FOR EVALUATION. (4111/3233) ATTEMPTS TO CONTACT THE USER TO GET MORE INFORMATION ON THE INVOLVED PRODUCT ARE ONGOING. AS THE PRODUCT SERIAL NUMBER HAS NOT BEEN PROVIDED YET, NO INVESTIGATION CAN BE INITIATED. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.