CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-09-20 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..

Event Text Entries

[717155] Sensor was inadvertently placed above the stent graft by the user. The sensor would not easily release from the delivery catheter. Eventually the sensor and delivery system were removed but this prolonged the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004936110-2007-00015
MDR Report Key921713
Report Source07
Date Received2007-09-20
Date of Report2007-09-20
Date of Event2007-09-14
Date Mfgr Received2007-09-15
Date Added to Maude2007-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street387 TECHNOLOGY CIRCLE, NW SUITE 500
Manufacturer CityATLANTA GA 30313
Manufacturer Postal30313
Manufacturer Phone6786512323
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDIOMEMS ENDOSURE DELIVERY SYSTEM
Generic NameINTRAVASCULAR PRESSURE SENSOR
Product CodeNQH
Date Received2007-09-20
Catalog NumberS2-2080
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key909423
ManufacturerCARDIOMEMS, INC.
Manufacturer AddressATLANTA GA 30313


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-09-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.