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Adverse Event Report

ETHOX CORP REPLACEABLE PRESSURE INFUSOR BAG ANGIOGRAPHY ACCESSORY   back to search results
Catalog Number SF4005
Device Problem Pressure, decreased
Event Date 08/05/2003
Patient Outcome  Other; Required Intervention
Event Description

During an interventional radiology procedure while placing a stent in the right iliac artery, the pressure bag failed to hold pressure. The pt's right femoral arterial sheath clotted. It is alleged that this occurred because the pressure bag failed to hold pressure. Thrombolytic therapy was started and the pt was transferred to the icu.

 
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Brand NameREPLACEABLE PRESSURE INFUSOR BAG
Type of DeviceANGIOGRAPHY ACCESSORY
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHOX CORP
251 seneca st
buffalo NY 14204 2088
Manufacturer (Section D)
ETHOX CORP
251 seneca st
buffalo NY 14204 2088
Device Event Key472531
MDR Report Key483650
Event Key458485
Report Number483650
Device Sequence Number1
Product CodeKZD
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 09/12/2003,08/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSF4005
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/15/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2003
Distributor Facility Aware Date09/05/2003
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer09/12/2003
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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