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Adverse Event Report

ACS/DVI ACS-RX COMET DILATION CATHETER   back to search results
Model Number 3.0MM-20MM
Event Date 03/14/1997
Patient Outcome  Hospitalization; Required Intervention
Event Description

Balloon separated from metal shaft and remained in left main artery when shaft was withdrawn. 3 attempts were made to snare balloon. Pt was transported to surgery for cabg. Small portion remains after open heart.

 
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Brand NameACS-RX COMET
Type of DeviceDILATION CATHETER
Baseline Brand NameACS RX COMET CORONARY DILATATION CATHETER
Baseline Generic NameCORONARY DILATATION CATHETER
Baseline Catalogue Number1001179-20
Baseline Device FamilyDILATATION CATHETERS
Baseline Device 510(K) Number
Baseline Device PMA NumberP810046
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed11/18/1996
Manufacturer (Section F)
ACS/DVI
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section D)
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd
temecula CA 92591 4628
Device Event Key78863
MDR Report Key79259
Event Key74642
Report Number79259
Device Sequence Number1
Product CodeLOX
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/1999
Device MODEL Number3.0MM-20MM
Device Catalogue Number100179-20
Device LOT Number6123151
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/14/1997
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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