HEMASHIELD GOLD KNITTED STRAIGHT
Received Apr 1, 2025 · Event occurred Mar 13, 2025
Report 1640201-2025-0000005 · MDR key 21736765
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M002020952080Catalog number
M002020952080
Lot number
24E01
Product problems
- Defective Device
- Defective Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(10/213)THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION WAS PERFORMED WAS PERFORMED BY A QUALITY CONTROL TECHNICIAN, THE PRODUCTION SUPERVISOR AND THE QUALITY ASSURANCE ENGINEER. IT WAS CONCLUDED THAT THE INVOLVED DEVICE IS CONFORM TO THE PRODUCT DIMENSIONAL SPECIFICATIONS. THE LENGTH MEASURED OF THE PRODUCT UNDER TENSION IS 61 CM (67) BASED ON THE INVESTIGATION FINDINGS, IN PARTICULAR THE PRODUCT VISUAL INSPECTION, IT WAS CONCLUDED THAT THE PRODUCT IS CONFORM TO THE PRODUCT DIMENSIONAL SPECIFICATIONS. IT SHOULD BE NOTED THAT, AS PER THE INSTRUCTIONS-FOR-USE OF HEMASHIELD GOLD KNITTED GRAFT, THE TOTAL GRAFT LENGTH PRINTED ON THE PRODUCT LABEL IS THE MINIMUM USABLE LENGTH. ACCORDING TO OUR PROCEDURES AND IN ACCORDANCE WITH THE APPLICABLE INTERNATIONAL STANDARD ISO 7198, THE USABLE LENGTH OF VASCULAR GRAFTS IS MEASURED WHEN GRAFT IS STRETCHED AT A MEDIUM TENSION WITHOUT COMPLETELY ELIMINATING THE EMBOSSING RINGS.
Description of Event or Problem
COMPLAINT #(B)(4).
Description of Event or Problem
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE STAFF OPENED THE INVOLVED DEVICE, REFERENCE: M002020952080, DIMENSION 8MMX60CM, THEY NOTICED THE GRAFT WAS NOT AS LONG AS IT SHOULD BE. IT IS ABOUT 30CM INSTEAD OF 60CM. THE SEALED POUCH HAS NOT BEEN OPENED.
Additional Manufacturer Narrative
(10/3233) IT WAS REPORTED THAT THE INVOLVED DEVICE IS AVAILABLE, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24E01. (4121/3233) THE DEVICE HISTORY RECORDS REVIEW IS PENDING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative
(10/3233) THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. PRODUCT ANALYSIS BY THE QUALITY ASSURANCE DEPARTMENT IS PENDING. (4121/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (11) 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).