HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020954080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-01 for HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020954080 manufactured by Intervascular Sas.

Event Text Entries

[137570076] Device is not accessible for testing as it remained implanted in patient. 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. These tests include a 100% visual inspection of the graft. Specifically, the review of the collagen coating records evidenced no anomaly. A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified. A visual inspection by the qa department will be performed. The review of post-marketing historical data indicated that no other similar 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.
Patient Sequence No: 1, Text Type: N, H10


[137570077] Two vascular grafts were sutured together and were used on the same patient (see manufacturer report 1640201-2019-00012 for the other involved device). When suturing the grafts to be implanted, it was noticed that the collagen coating was crumbling like bread crumbs. The surgeon wet the grafts with sterile saline and no more crumbling was noticed. The grafts were implanted in the abdominal area with no other signs of issues or complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1640201-2019-00013
MDR Report Key8382219
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-03-01
Date of Report2019-05-03
Date of Event2019-01-30
Date Mfgr Received2019-04-03
Device Manufacturer Date2018-06-13
Date Added to Maude2019-03-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. LAURE FRAYSSE
Manufacturer StreetZ.I. ATHELIA I
Manufacturer CityLA CIOTAT CEDEX, 13705
Manufacturer CountryFR
Manufacturer Postal13705
Manufacturer G1INTERVASCULAR SAS
Manufacturer StreetZ.I. ATHELIA I
Manufacturer CityLA CIOTAT CEDEX, 13705
Manufacturer CountryFR
Manufacturer Postal Code13705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR
Generic NameVASCULAR POLYESTER GRAFT
Product CodeMAL
Date Received2019-03-01
Model NumberM002020954080
Catalog NumberM002020954080
Lot Number18F13
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERVASCULAR SAS
Manufacturer AddressZ.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.