GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008114-0C NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-08-22 for GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE 1008114-0C NA manufactured by Guidant Vascular Intervention.

Event Text Entries

[291448] The site was performing a tandem treatment. The proximal reference lumen diameter (rld) was determined to be 3. 3 mm and the distal rld was determined to be 2. 8 mm. The proximal segment was treated successfully. The rld value for the distal segment was mistakenly entered as 3. 3 mm rather than 2. 8 mm as was measured. The site investigated the possible misadministration with the depth dose tables provided in the galileo instructions for use. The site calculated the dose delivered to be 26. 4gy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1651662-2003-00010
MDR Report Key483415
Report Source05,06,07
Date Received2003-08-22
Date of Report2003-07-25
Date of Event2002-06-20
Date Mfgr Received2003-07-25
Date Added to Maude2003-09-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHYSICIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDENISE VINMANS
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9099142050
Manufacturer G1GUIDANT, HOUSTON
Manufacturer Street8934 KIRBY DRIVE
Manufacturer CityHOUSTON TX 77054
Manufacturer CountryUS
Manufacturer Postal Code77054
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameGALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Generic NameRADIATION SYSTEM CARTRIDGE
Product CodeMOU
Date Received2003-08-22
Returned To Mfg2002-07-12
Model Number1008114-0C
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key472311
ManufacturerGUIDANT VASCULAR INTERVENTION
Manufacturer Address26531 YNEZ ROAD TEMECULA CA 92591 US
Baseline Brand NameGALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Baseline Generic NameRADIATION SYSTEM CARTRIDGE
Baseline Model No1008114-0C
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyRADIATION SYSTEM CARTRIDGE
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagY
Premarket ApprovalP0000
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2003-08-22

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