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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICS; VASCULAR POLYESTER GRAFT
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INTERVASCULAR SAS HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICS; VASCULAR POLYESTER GRAFT Back to Search Results
Model Number M002000195140
Device Problem Product Quality Problem (1506)
Patient Problem No Patient Involvement (2645)
Event Date 10/04/2018
Event Type  malfunction  
Manufacturer Narrative
To date, the serial number of the concerned patch is not available, only the lot number was confirmed.
 
Event Description
During a carotid endarterectomy, a first patch was implanted but looked "more yellow" and it felt "fuzzier and thicker" than previous used patches (see manufacturer report 1640201-2018-00021 for this first involved device).The surgeon opened a second box (sterile pack remained closed) with a different lot number.This second patch looked the same and is the subject of the present report.
 
Manufacturer Narrative
(b)(4).The returned device was visually inspected by our qa supervisor.No anomaly was found, the patch complies with our product specifications.(b)(4) the conducted investigation indicates that the product was not defective.
 
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Brand Name
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICS
Type of Device
VASCULAR POLYESTER GRAFT
Manufacturer (Section D)
INTERVASCULAR SAS
z.i. athelia i
la ciotat cedex, 13705
FR  13705
MDR Report Key8024893
MDR Text Key125676886
Report Number1640201-2018-00022
Device Sequence Number1
Product Code DXZ
UDI-Device Identifier00384401017899
UDI-Public00384401017899
Combination Product (y/n)N
PMA/PMN Number
K955349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date11/30/2022
Device Model NumberM002000195140
Device Catalogue NumberM002000195140
Device Lot Number17M13
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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