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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN STRAIGHT; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
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INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN STRAIGHT; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE Back to Search Results
Model Number M00202175428P0
Medical Device Problem Code Product Quality Problem (1506)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/21/2026
Type of Reportable Event Malfunction
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Brand Name
HEMASHIELD PLATINUM WOVEN STRAIGHT
Common Device Name
GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Manufacturer (Section D)
INTERVASCULAR SAS
zone industrielle athelia i
la ciotat 13705
FR  13705
Manufacturer (Section G)
INTERVASCULAR SAS
zone industrielle athelia i
la ciotat 13705
FR   13705
Manufacturer Contact
clemence vaneenoge
zone industrielle athelia i
la ciotat 13705
FR   13705
442084646
MDR Report Key25837784
Report Number1640201-2026-0000033
Device Sequence Number18581917
Product Code MAL
UDI-Device Identifier00384401018247
UDI-Public(01)00384401018247
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K021213
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/16/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberM00202175428P0
Device Catalogue NumberM00202175428P0
Device Lot Number25H06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2026
Initial Report FDA Received Date07/16/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured08/06/2025
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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