THE GREENFILED RIGHT VENA CAVA FILTER 50-300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-05 for THE GREENFILED RIGHT VENA CAVA FILTER 50-300 manufactured by Medi-tech, Boston Scientific Corporation.

Event Text Entries

[4170] The 64 year old, male, in satisfactory condition underwent trans jugular placement of an inferior vena cava filter. After successful placement of the filter the 64 year old, male in satisfactory condition expired. Medical personnel became aware the device may or may not have been a direct cause of the event on 3/11/1993device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5655
MDR Report Key5655
Date Received1993-04-05
Date of Report1993-03-15
Date of Event1993-02-12
Date Facility Aware1993-03-11
Report Date1993-03-15
Date Reported to Mfgr1993-03-11
Date Added to Maude1993-07-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTHE GREENFILED RIGHT VENA CAVA FILTER
Generic NameUNKNOWN
Product CodeDST
Date Received1993-04-05
Model Number50-300
Catalog Number50-300
Lot Number63942
ID NumberUNKNOWN
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Age01-FEB-93
Implant FlagY
Device Sequence No1
Device Event Key5354
ManufacturerMEDI-TECH, BOSTON SCIENTIFIC CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1993-04-05

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