HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-05 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.

Event Text Entries

[2460074] During the procedure, it was reported the balloon could not be deflated. The inflated balloon was successfully removed from the pt. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5


[9562761] The balloon catheter has been evaluated and a large amount of blood was found in the balloon lumen. Based upon the findings, the large amount of blood found in the balloon assembly was the likely cause of the non-deflation. The instruction for use warns "inadvertent proximal guidewire movement can cause blood to enter the balloon lumen which may inhibit balloon deflation. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2029214-2011-00286
MDR Report Key2371430
Report Source04
Date Received2011-10-05
Date of Report2011-09-06
Date of Event2011-08-20
Date Mfgr Received2011-09-06
Date Added to Maude2012-03-13
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 ContactKIM SALCEDA
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9498373700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYPERFORM OCCLUSION BALLOON SYSTEM
Generic NameOCCLUSION BALLOON CATHETER, NUF
Product CodeNUF
Date Received2011-10-05
Model Number104-4470
Lot Number9429586
Device Expiration Date2014-02-01
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEV3 NEUROVASCULAR
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-05

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