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 04,05,06 report with the FDA on 2012-03-06 for HYPERFORM OCCLUSION BALLOON SYSTEM 104-4470 manufactured by Ev3 Neurovascular.

Event Text Entries

[2395088] It was reported when opening the package, a kink was observed at the distal end of the system. The device was not used in the patient.
Patient Sequence No: 1, Text Type: D, B5


[9671683] The device has been evaluated. The evaluation showed that the guidewire broke into two segments (due to torsion overload) inside the catheter lumen and one of the segments punctured the catheter lumen at 1. 5 cm from the distal tip. Catheter lumen. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2029214-2012-00106
MDR Report Key2480614
Report Source04,05,06
Date Received2012-03-06
Date of Report2012-02-10
Date of Event2012-01-24
Date Mfgr Received2012-02-10
Device Manufacturer Date2011-11-28
Date Added to Maude2012-08-27
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 ContactHENRY TO
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9498601335
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYPERFORM OCCLUSION BALLOON SYSTEM
Generic NameOCCLUSION BALLOON CATHETER
Product CodeNUF
Date Received2012-03-06
Returned To Mfg2012-02-17
Model Number104-4470
Lot Number9519522
Device Expiration Date2014-09-01
OperatorPHYSICIAN
Device AvailabilityR
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 2012-03-06

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