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 2008-12-17 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..

Event Text Entries

[1031007] A buddy wire was used during the insertion of the stent graft and sensor. While removing the guide catheter, the buddy wire was accidentally withdrawn. Upon reinsertion the buddy wire was located inside of the stent graft resulting in release of the sensor by the physician within the stent graft after the aneurysm was sealed. A snare was inserted and the sensor was removed from the patient. No additional sensor was placed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004936110-2008-00008
MDR Report Key1321709
Report Source07
Date Received2008-12-17
Date of Report2008-12-16
Date of Event2008-11-19
Date Mfgr Received2008-11-20
Date Added to Maude2009-11-17
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 CountryUS
Manufacturer Postal30313
Manufacturer Phone6786512300
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDIOMEMS ENDOSURE DELIVERY SYSTEM
Generic NameINTRAVASCULAR PRESSURE SENSOR
Product CodeNQH
Date Received2008-12-17
Catalog NumberS2-2080
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARDIOMEMS, INC.
Manufacturer AddressATLANTA GA 30313 US 30313


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-12-17

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