HEMASHIELD PLATINUM WOVEN STRAIGHT

Additional Manufacturer Narrative

(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 25B05. (3331/3233) THE DEVICE HISTORY RECORDS REVIEW IS PENDING. (10/3233) A NON-IMPLANTED FRAGMENT OF THE INVOLVED DEVICE WHICH WAS CONTAMINATED WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE INVESTIGATION IS ONGOING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT THE SURGEON AND THE NURSES EXPERIENCED THAT THREADS FROM THE PROSTHESIS FELL DOWN ONTO THE OPERATION FIELD BUT IT WAS CONFIRMED THAT IT DID NOT FALL IN THE PATIENT. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

(3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. (4110/213) THE OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS ON THE SAME PRODUCT FAMILY (HEMASHIELD GRAFT AND PATCH) FOR THE PERIOD 01-SEP-2024 TO 31-AUG-2025. THE CALCULATED OCCURRENCE RATE IS 0.004%, WHICH IS BELOW THE ANTICIPATED OCCURRENCE RATE (MAXIMUM) OF 0.01%. (10/213) A NON IMPLANTED FRAGMENT OF THE INVOLVED DEVICE WHICH WAS CONTAMINATED WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION, MACROSCOPIC ANALYSIS DID NOT REVEAL ANY MACROSCOPIC DEFECTS IN TEXTILE STRUCTURE. NO FRAYING WAS OBSERVED DURING THE ANALYSIS. (4111/4248) COMMUNICATION WITH THE END USER CONFIRMED THE USE OF SCISSOR TO CUT THE GRAFT " DURING THE OPERATION, THE PRODUCT (1586376652, 25B05), WHICH IS THE SUBJECT OF THE COMPLAINT, WAS CUT WITH SCISSORS." (67/18) BASED ON THE INVESTIGATION FINDINGS THE PROBABLE CAUSE OF THE EVENT IS RELATED TO THE CUTTING OF THE PROSTHESIS WITH SCISSORS. INDEED, AS PER INSTRUCTION FOR USE OF HEMASHIELD PLATINUM WOVEN VASCULAR GRAFTS, DUE TO THEIR INTRINSIC WEAVING PATTERN, WOVEN GRAFTS ARE MORE PRONE TO FRAYING. THE WARNING SECTION STATES THAT WOVEN GRAFTS SHOULD NOT CUT WITH SCISSORS OR SCALPELS TO LIMIT THE RISK OF GRAFT FRAYING. IN ADDITION, THE SECTION DIRECTIONS FOR USE OF THE IFU STATED THE FOLLOWING: ¿AS WITH ALL THE WOVEN PRODUCTS, THE HEMASHIELD PLATINUM WOVEN VASCULAR GRAFTS SHOULD BE CUT WITH A LOW TEMPERATURE DISPOSABLE CAUTERY (E.G., 900°F / 500°C) TO MINIMIZE FRAYING.

Description of Event or Problem

COMPLAINT # (B)(4).

Additional Manufacturer Narrative

CORRECT DATA: BLOCK D4. DURING THE COMPLAINT CLOSURE REVIEW ON 24-SEPTEMBER-2025, WE IDENTIFIED THAT THE UNIQUE DEVICE IDENTIFIER (UDI) REPORTED IN THE INITIAL SUBMISSION (INITIAL MDR #1640201-2025-0000019 SUBMITTED ON 11-JULY-2025) WAS INCORRECT DUE TO A DATA ENTRY ERROR. THE UDI HAS BEEN CORRECTED IN THIS CORRECTIVE FOLLOW UP REPORT. NO OTHER DATA HAVE BEEN CHANGED, AND THIS CORRECTION DOES NOT ALTER THE EVENT ASSESSMENT OR CONCLUSIONS.

Description of Event or Problem

COMPLAINT # (B)(4).