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Adverse Event Report

ACS/DVI ADVANCED CARDIOVASCULAR SYSTEMS ACS HI-TORQUE FLOPPY II GUIDE WIRE   back to search results
Catalog Number REF 22339M
Event Date 07/11/1997
Patient Outcome  Hospitalization;
Event Description

Ptca procedure. Wire down lad and another down diagonal. At end of case wires removed diagonal wire tip had fractured. On next picture contrast was seen breaking out of vessel, hr, bp. Additional surgery performed, wire tip still in patient.

 
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Brand NameADVANCED CARDIOVASCULAR SYSTEMS
Type of DeviceACS HI-TORQUE FLOPPY II GUIDE WIRE
Baseline Brand NameHIGH TORQUE FLOPPY II .014" GUIDE WIRE
Baseline Generic NameGUIDE WIRES
Baseline Catalogue Number22339M
Baseline Device FamilyGUIDE WIRES
Baseline Device 510(K) NumberK913353
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed05/05/1988
Manufacturer (Section F)
ACS/DVI
26531 ynez rd
temecula CA 92591
Manufacturer (Section D)
ADVANCED CARDIOVASCULAR SYSTEMS INC.
3200 lakeside drive
santa clara CA 95052
Device Event Key104764
MDR Report Key106574
Event Key100182
Report Number106574
Device Sequence Number1
Product CodeDQX
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/1997
Is This An Adverse Event Report? No
Device Operator Health Professional
Device EXPIRATION Date06/01/1999
Device Catalogue NumberREF 22339M
Device LOT Number7052051
OTHER Device ID Number0.014" 190CM
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/1997
Distributor Facility Aware Date07/14/1997
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer07/16/1997
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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