N/A 11165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-07 for N/A 11165 manufactured by Ascent Halthcare Solutions.

Event Text Entries

[1491410] It was reported that during an unknown procedure, the femostop seal was leaking and caused the patient to have a pseudo aneurysm which required a surgical resection to correct. The patient was reported to be in satisfactory condition after the procedure.
Patient Sequence No: 1, Text Type: D, B5


[8566676] At the time of this report the device investigation had not been completed. Once the investigation is completed, a follow-up mdr will be submitted. This is the first complaint ascent has received for a femostop causing a pseudo aneurysm.
Patient Sequence No: 1, Text Type: N, H10


[19748864] This mdr is associated with an ascent voluntary recall for six (6) femostop lot numbers where the device may fail to inflate properly and may leak due to a seal separation between the dome and plastic arch base. On june 18th ascent initiated a voluntary recall for the six femostop lot numbers so this follow-up mdr is being filed due to the additional information obtained during the recall. The patient information was not provided to ascent.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1056128-2010-00011
MDR Report Key1677121
Report Source05,06,07
Date Received2010-05-07
Date of Report2010-07-15
Date of Event2010-04-09
Date Mfgr Received2010-06-18
Device Manufacturer Date2009-11-30
Date Added to Maude2010-07-15
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 ContactMS. MOIRA BARTON-VARTY
Manufacturer Street10232 S. 51ST STREET
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal85044
Manufacturer Phone4807635300
Manufacturer G1ASCENT HALTHCARE SOLUTIONS
Manufacturer Street5307 GREAT OAK DRIVE
Manufacturer CityLAKELAND FL 33815
Manufacturer CountryUS
Manufacturer Postal Code33815
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameNMF
Product CodeNMF
Date Received2010-05-07
Returned To Mfg2010-04-21
Model Number11165
Catalog Number11165
Lot Number880274
Device Expiration Date2010-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENT HALTHCARE SOLUTIONS
Manufacturer Address5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2010-05-07

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