DELIVERY CATHETER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-09 for DELIVERY CATHETER * manufactured by Novoste Corp.

Event Text Entries

[353124] Pt having right renal artery brachytherapy done. During seed extraction, seeds got stuck in delivery catheter. Catheter secured in lead box. No risk or harm to pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number554381
MDR Report Key554381
Date Received2004-11-09
Date of Report2004-11-05
Date of Event2004-11-05
Date Facility Aware2004-11-05
Report Date2004-11-05
Date Reported to FDA2004-11-05
Date Reported to Mfgr2004-11-05
Date Added to Maude2004-11-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDELIVERY CATHETER
Generic Name3.5 DELIVERY CATHETER & PROCEDURE ACCESSORY KIT
Product CodeMOU
Date Received2004-11-09
Model Number*
Catalog Number*
Lot Number712654
ID NumberREF ABR-0346
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key544009
ManufacturerNOVOSTE CORP
Manufacturer Address3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-11-09

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