inforMED
MalfunctionMAL

HEMASHIELD PLATINUM - WOVEN DOUBLE VELOUR VASCULAR GRAFT

Received Nov 29, 2019 · Event occurred Nov 5, 2019

Report 1640201-2019-00087 · MDR key 9391872

Device

Generic name

Graft, Vascular, Synthetic/biologic Composite

Manufacturer

Intervascular Sas

Model number

M00202175416P0

Catalog number

M00202175416P0

Lot number

19E01

Product problems

  • Material Frayed
  • Material Frayed

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT . THE DEVICE HISTORY RECORDS REVIEW CONCLUDES THAT THERE IS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. THE DEVICE WAS NOT RETURNED YET.

Description of Event or Problem

SURGEON CUT THE GRAFT WITH SCISSORS FOR USE ON THE PATIENT, BUT A LOT OF SEAMS APPEARED ON THE CUT SURFACE OF THE GRAFT. USER REPLACED THE PRODUCT WITH HGK0014-40 TO COMPLETE THE OPERATION. NO PATIENT INFO FROM THIS HOSPITAL.

Description of Event or Problem

SEE INITIAL MFR REPORT # (B)(4). COMPLAINT # (B)(4). ADDITIONAL INFORMATION: "THE SURGEON CUT THE GRAFT USING A GENERAL SURGICAL SCISSOR (METZENBAUM SCISSOR)."

Additional Manufacturer Narrative

(10/213) THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS VISUALLY INSPECTED BY OUR QUALITY ASSURANCE (QA) SUPERVISOR. THE CONCLUSIONS ARE: "THE DISCREPANCY IS CONFIRMED, THE GRAFT IS FRAYED ¿ ¿EXCEPT THE PART CUT BY THE SURGEON, THE REST OF THE GRAFT IS COMPLIANT". ¿IT IS NOT POSSIBLE TO CONCLUDE THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING BECAUSE THE RETURNED PRODUCT EXAMINED IS DEFECTIVE NOW, HOWEVER IT IS UNLIKELY THAT THE GRAFT WAS LIKE THIS AT FACTORY LEAVE¿. (67) THE CONDUCTED INVESTIGATION SUGGESTS THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. (61) UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. INDEED, DURING THE INVESTIGATION, WE WERE INFORMED THAT "THE SURGEON CUT THE GRAFT USING A GENERAL SURGICAL SCISSOR (METZENBAUM SCISSOR)". HOWEVER, DUE TO THEIR INTRINSIC WEAVING PATTERN, WOVEN GRAFTS ARE PRONE TO FRAYING WHEN CUT WITH SCISSORS . AS INDICATED IN THE PRODUCT INSTRUCTIONS FOR USE, A LOW-TEMPERATURE DISPOSABLE CAUTERY SHOULD BE USED TO MINIMIZE FRAYING WHEN CUTTING THIS GRAFT.