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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV 28MM 30CM HEMASHIELD PLAT WDV; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
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MAQUET CV 28MM 30CM HEMASHIELD PLAT WDV; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE Back to Search Results
Catalog Number VS02175428P0
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.
 
Event Description
The hospital reported that during an ascending aorta repair, the graft was opened on the field at the doctor's request.When he visualized the graft, he felt there was some adhesive visible on one end of the graft that should not be there.The graft was not used for this reason.It was removed from the field and a new graft, same size, was opened.
 
Manufacturer Narrative
On (b)(6) 2016 04:19 pm (gmt-5:00) added by (b)(6) ((b)(4)): the device history record (dhr) was reviewed.The records show the device lot conformed to all applicable specifications.The dhr is available for review as an attachment to the record.(b)(4).
 
Event Description
The hospital reported that during an ascending aorta repair, the graft was opened on the field at the doctor's request.When he visualized the graft, he felt there was some adhesive visible on one end of the graft that should not be there.The graft was not used for this reason.It was removed from the field and a new graft, same size, was opened.
 
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Brand Name
28MM 30CM HEMASHIELD PLAT WDV
Type of Device
GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key5188748
MDR Text Key30325201
Report Number2242352-2015-01214
Device Sequence Number1
Product Code MAL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Catalogue NumberVS02175428P0
Device Lot Number25095359
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age YR
Date Manufacturer Received01/26/2016
Date Device Manufactured04/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age60 YR
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