CELLO BALLOON GUIDE CATHETER 1610580

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-29 for CELLO BALLOON GUIDE CATHETER 1610580 manufactured by Micro Therapeutics, Inc. Dba Ev3 Neurovascular.

Event Text Entries

[39249725] The device will not be returned for analysis as it was discarded; therefore the complaint could not be determined. Same event as reported in mdr mfr: 2029214-2016-00120.
Patient Sequence No: 1, Text Type: N, H10


[39249726] Medtronic received information that during a mechanical thrombectomy procedure in the internal carotid artery (ica), the cello balloon burst and leaked upon inflation. No patient injury as a result of this event. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2016-00121
MDR Report Key5466967
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-02-29
Date of Report2016-02-03
Date of Event2016-01-27
Date Mfgr Received2016-02-03
Device Manufacturer Date2015-11-17
Date Added to Maude2016-02-29
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 Location3
Manufacturer ContactTRICHA MILES
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9498373700
Manufacturer G1MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELLO BALLOON GUIDE CATHETER
Generic NameCATHETER, NEURO-VASCULATURE, OCCLUDING BALLON
Product CodeNUF
Date Received2016-02-29
Model Number1610580
Lot Number5500188
Device Expiration Date2018-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-29

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