3.5F BETA-RAIL DELIVERY CATHETER P00563 ABR-0340

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-06-06 for 3.5F BETA-RAIL DELIVERY CATHETER P00563 ABR-0340 manufactured by Novoste Corp..

Event Text Entries

[273912] The radioactive sources were left in the pt at the treatment site for a 30 second delay after the intended treatment time. Pt is in stable condition. The site indicated that they were reporting the radiation event to the state.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1062385-2003-00009
MDR Report Key465393
Report Source05,07
Date Received2003-06-06
Date of Report2003-06-06
Date of Event2003-05-19
Date Mfgr Received2003-05-21
Device Manufacturer Date2003-01-01
Date Added to Maude2003-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactADAM LOWE, VP
Manufacturer Street3890 STEVE REYNOLDS BLVD
Manufacturer CityNORCROSS GA 30093
Manufacturer CountryUS
Manufacturer Postal30093
Manufacturer Phone7707170904
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3.5F BETA-RAIL DELIVERY CATHETER
Generic NameCATHETER
Product CodeMOU
Date Received2003-06-06
Model NumberP00563
Catalog NumberABR-0340
Lot Number614298
ID NumberNA
Device Expiration Date2005-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key454337
ManufacturerNOVOSTE CORP.
Manufacturer Address3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US
Baseline Brand NameBETA-RAIL 35F DELIVERY CATHETER
Baseline Generic NameCATHETER
Baseline Model NoP00563
Baseline Catalog NoABR-0340
Baseline IDNA
Baseline Device FamilyBETA-RAIL 3.5F DELIVERY CATHETER
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagY
Premarket ApprovalP0000
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-06-06

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