CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001

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 2007-08-14 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..

Event Text Entries

[19494268] Delivery system was advanced through tortuous anatomy and nose cone detached from delivery system. Nose cone remained on guidewire and was successfully retrieved with snare. No sensor was implanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004936110-2007-00011
MDR Report Key898078
Report Source07
Date Received2007-08-14
Date of Report2007-08-14
Date of Event2007-08-13
Date Mfgr Received2007-06-13
Date Added to Maude2009-07-08
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 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 Received2007-08-14
Catalog NumberADS-1001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
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 2007-08-14

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