HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175826P0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-11 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175826P0 manufactured by Intervascular Sas.

Event Text Entries

[141591476] Device is not accessible for testing as it remained implanted in the 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 using a backlit table to reveal the presence of any holes in the textile structure. 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


[141591477] Two holes were found between the perfusion branch and the main body of the graft. It was reported that the first hole was closed by pledget suture and the second hole was closed by 5/0 prolene with pledget suture. No injury to the patient was reported. A video and pictures were provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1640201-2019-00022
MDR Report Key8503666
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-11
Date of Report2019-04-11
Date of Event2019-03-04
Date Mfgr Received2019-03-12
Device Manufacturer Date2018-10-03
Date Added to Maude2019-04-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 PLATINUM WOVEN DOUBLE VELOUR
Generic NameVASCULAR POLYESTER GRAFT
Product CodeMAL
Date Received2019-04-11
Model NumberM00202175826P0
Catalog NumberM00202175826P0
Lot Number18K03
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
101. Required No Informationntervention 2019-04-11

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