HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
Received Mar 1, 2019
Report 1640201-2019-00016 · MDR key 8382786
Device
Generic name
Vascular Polyester Graft
Manufacturer
Intervascular SasModel number
M00202175208P0Catalog number
M00202175208P0
Lot number
18F06
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
(3331/213) A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. SPECIFICALLY, NO ANOMALY WAS EVIDENCED IN THE COLLAGEN COATING RECORDS. MOREOVER, THE REVIEW OF THE WATER PERMEABILITY TESTING RECORDS OF A PRODUCT OF THE SAME LOT AND COATED ON THE SAME DAY AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). (4101/4103/213) SEVEN UNOPENED ORIGINAL PACKAGING GRAFTS WERE RETURNED BY THE CUSTOMER TO INTERVASCULAR AND WERE VISUALLY INSPECTED BY OUR QUALITY ASSURANCE (QA) MANAGER. NO ANOMALY WAS FOUND, ALL SEVEN PRODUCTS COMPLY WITH THEIR SPECIFICATIONS. AMONG THE SEVEN PRODUCTS RETURNED, TWO BELONG TO THE SAME LOT AND WERE COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE. THEY UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULTS INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). (67) NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGEST THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING.
Additional Manufacturer Narrative
DEVICE IS NOT ACCESSIBLE FOR TESTING. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS IS ONGOING; RESULTS ARE PENDING. TWO UNOPENED DEVICES FROM SAME LOT WILL BE RETURNED FROM THE CUSTOMER. THEY WILL UNDERGO WATER PERMEABILITY TESTING. THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
FOLLOWING A RETURN OF UNOPENED ORIGINAL PACKAGING GRAFTS FOR CREDIT, IT WAS REPORTED THAT SURGEONS DO NOT WANT TO USE THIS GRAFT TYPE ANYMORE SINCE THE INVOLVED GRAFT LEAKED/OOZED BLOOD WHEN IMPLANTED. THERE WAS NO INJURY TO THE PATIENT BUT EVENT DETAILS ARE UNAVAILABLE (DATE, DESCRIPTION, INCIDENT HANDLING).