HEMASHIELD PLATINUM WOVEN STRAIGTH

Additional Manufacturer Narrative

(10/4248) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR. A VISUAL INSPECTION WAS PERFORMED BY THE QUALITY ASSURANCE (QA) SUPERVISOR, WHO OBSERVED THAT THE PRODUCT HAS BEEN MANIPULATED BY THE CUSTOMER AND WAS CUT INTO TWO PARTS. INDEED, THE PRODUCT BOX WAS OPENED AND SOME COMPONENTS OF THE PACKAGING WERE MISSING. THE GRAFT PRESENTED PULLED THREADS ON THE FRAGMENT WITH NON-FREE ENDS. THERE WAS NO FRAYING ON THE CLEANLY CUT SIDE OF THE LONGEST FRAGMENT. (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO DEVIATION IDENTIFIED RELATED TO THE REPORTED EVENT. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 23F07. (61) BASED ON THE INVESTIGATION FINDINGS, NO CONCLUSION CAN BE DRAWN ON THE EXACT ORIGIN OF THE REPORTED FRAYING. FOLLOWING THE INVOLVED PRODUCT INSPECTION, THE CAUSE OF THE INCIDENT IS UNKNOWN SINCE THE PRODUCT HAS BEEN CUT BY THE CUSTOMER AND NO INFORMATION REGARDING THE TYPE OF SCISSORS USED WAS PROVIDED. IN CONCLUSION, THE RESULTS OF THE INVESTIGATION 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 DURING THE CUTTING OF THE PRODUCT. PLEASE NOTE THAT THE FOLLOWING MENTION IS PRESENT AS A WARNING IN THE PRODUCT INSTRUCTIONS FOR USE (IFU): "DUE TO THEIR INTRINSIC WEAVING PATTERN, WOVEN GRAFTS ARE MORE PRONE TO FRAYING. DO NOT CUT WOVEN GRAFTS WITH SCISSORS OR SCALPELS TO LIMIT THE RISK OF GRAFT FRAYING". 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.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT AN HEMASHIELD PLATINUM WOVEN STRAIGHT WAS FRAYED. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER INDICATED THAT THE PRODUCT WAS DAMAGED WHEN THE NURSE OPENED THE PACKAGE. NO INFORMATION WAS PROVIDED ABOUT THE TYPE OF SCICORS THE SURGEON USED.