ENDOSURE AAA PRESSURE SENSOR/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 2006-05-02 for ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..

Event Text Entries

[20026223] During insertion of the endosure aaa pressure sensor into a calcified iliac artery, the delivery cathter detached. Removal of the tip was successfully performed. The case was completed and the pt was discharged from the hosp without incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004936110-2006-00001
MDR Report Key708713
Report Source07
Date Received2006-05-02
Date of Report2006-05-01
Date of Event2006-04-24
Date Mfgr Received2006-04-24
Device Manufacturer Date2005-12-01
Date Added to Maude2006-05-09
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 FDA3
Event Location0
Manufacturer Street75 FIFTH ST, NW STE 404
Manufacturer CityATLANTA GA 30308
Manufacturer CountryUS
Manufacturer Postal30308
Manufacturer Phone4049206712
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM
Generic NameINTRASAC PRESSURE SENSOR/DELIVERY CATHETER
Product CodeNQH
Date Received2006-05-02
Returned To Mfg2006-04-24
Model NumberNA
Catalog NumberADS-1001
Lot Number11C013628
ID NumberNA
Device Expiration Date2007-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key697761
ManufacturerCARDIOMEMS, INC.
Manufacturer Address* ATLANTA GA * US
Baseline Brand NameENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM
Baseline Generic NameINTRASAC PRESSURE SENSOR/DELIVERY CATHETER
Baseline Model NoNA
Baseline Catalog NoADS-1001
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-05-02

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