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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY JOSTENT GRAFTMASTER

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ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY JOSTENT GRAFTMASTER Back to Search Results
Catalog Number 12745-16
Device Problems Difficult to deploy; Leak
Event Date 08/25/2010
Event Type  Death  
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Brand NameJOSTENT GRAFTMASTER
Manufacturer (Section D)
ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY
rudolf-diesel-strasse 29
rangendingen D-72 414
GERMANY D-72414
Manufacturer (Section G)
ABBOTT VASCULAR GERMANY
rudolf-diesel strasse 29
rangendingen D-72 414
GERMANY D-72414
Manufacturer Contact
kthleen reily
26531 ynez rd.
temecula , CA 92591-4628
9519143996
MDR Report Key1843959
Report Number2024168-2010-01978
Device Sequence Number1
Product CodeMAF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 08/27/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2011
Device Catalogue Number12745-16
Device LOT Number526252
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/27/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/21/2010 Patient Sequence Number: 1
Treatment
ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
(PART 1003382-13, LOT 0021141)
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