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 2011-09-29 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.

Event Text Entries

[2460069] It was reported that the guidewire (provided with the balloon system) broke inside the balloon catheter during procedure. The entire system was removed from the tp and the procedure continued with a new system. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5


[9562298] The guidewire was returned with approx 10 cm of the distal tip missing. Analysis of the break point showed the failure of the core wire occurred due to fatigue torsional overload. The balloon catheter was also returned and found ruptured. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2029214-2011-00276
MDR Report Key2371416
Report Source04
Date Received2011-09-29
Date of Report2011-08-30
Date of Event2011-08-25
Date Mfgr Received2011-08-30
Device Manufacturer Date2011-06-01
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 FDA0
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, NUF
Product CodeNUF
Date Received2011-09-29
Returned To Mfg2011-09-09
Model Number104-4470
Lot Number9449519
Device Expiration Date2014-04-01
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerEV3 NEUROVASCULAR
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2011-09-29

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