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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED AXILLO BIFEMORAL RADIALLY SUPPORTED GRAFT; VASCULAR POLYESTER GRAFT
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INTERVASCULAR SAS HEMAGARD KNITTED AXILLO BIFEMORAL RADIALLY SUPPORTED GRAFT; VASCULAR POLYESTER GRAFT Back to Search Results
Model Number HGKAX080606RS35/20
Medical Device Problem Code Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code Blood Loss (2597)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
During a cardiovascular surgery, the involved graft was reported to seep when declamping, especially at the unringed area.This resulted in a blood loss (about 100ml) each time clamps were released.The graft eventually stopped sweating by itself after a significant amount of time.No adverse consequence for the patient has been reported.
 
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Brand Name
HEMAGARD KNITTED AXILLO BIFEMORAL RADIALLY SUPPORTED GRAFT
Common Device Name
VASCULAR POLYESTER GRAFT
Manufacturer (Section D)
INTERVASCULAR SAS
zi athelia 1
la ciotat cedex, 13705
FR  13705
MDR Report Key5702807
Report Number1640201-2016-00014
Device Sequence Number18885582
Product Code DSY
UDI-Device Identifier00384401014430
UDI-Public00384401014430
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K964625
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date01/31/2020
Device Model NumberHGKAX080606RS35/20
Device Catalogue NumberHGKAX080606RS35/20
Device Lot Number15B05
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2016
Initial Report FDA Received Date06/07/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
HEPARIN
Outcome Attributed to Adverse Event Other;
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