HEMASHIELD PLATINUM WOVEN STRAIGHT
Received Oct 7, 2022 · Event occurred Sep 14, 2022
Report 1640201-2022-00029 · MDR key 15560161
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175426P0Catalog number
M00202175426P0
Lot number
21F02
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTING TO INTERVASCULAR THAT WHILE PREPARING FOR THE AORTIC DISSECTION SURGERY, A DISCOLORED AREA WAS DISCOVERED WITH MELTED COLLAGEN IN THE PRODUCT. THE OPERATION WAS COMPLETED WITH ANOTHER PRODUCT OF THE SAME MODEL STOCKED IN THE HOSPITAL. COMPLAINT #: (B)(4). PLEASE NOTE THAT THIS COMPLAINT IS ONE OF A SERIES OF TWO COMPLAINTS, THE SECOND COMPLAINT #: (B)(4) IS ALSO THE SUBJECT OF AN INITIAL EMDR REPORTING.
Additional Manufacturer Narrative
THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION IS PENDING. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 21F02. THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE/PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
COMPLAINT # (B)(4)
Additional Manufacturer Narrative
(10/213) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR ON 27-SEPT-2022 FOR EXAMINATION. A VISUAL INSPECTION BY A QUALIFIED QUALITY CONTROL TECHNICIAN WAS PERFORMED, THE CONCLUSION IS AS FOLLOW: "- NO IDENTIFIED DEFAULT; - NO LACK OF COLLAGEN; - IDENTIFICATION OF WHITE AND YELLOW STAINS IN RELATION WITH THE COLLAGEN." (67) THE CONDUCTED INVESTIGATION CONCLUDES THAT THE PRODUCT WAS CONFORM TO THE SPECIFICATION.