MARATHON 105-5056

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-27 for MARATHON 105-5056 manufactured by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular.

Event Text Entries

[182169816] The device has been received. Once the device is analyzed and the investigation is completed a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182169817] Medtronic received report that the marathon catheter was punctured by the chikai x10. The puncture was located about 2~3 mm from the tip of the marathon, and the tip of the wire exited out from the catheter side. No resistance was experienced when the guidewire was advanced through the marathon. No patient injury occurred, and the devices were removed. There was no damage to the guidewire. A new marathon catheter was used to treat the patient. Transarterial embolization (tae) case using arteriovenous malformation (avm) liquid embolus (n-butyl-2-cyanoacrylate (nbca). The vessel anatomy was moderate in tortuosity. The case time was long (five and a half hours). The patient was exposed to a high dose of fluor, the procedure was completed in consideration of risk.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00170
MDR Report Key9764653
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-27
Date of Report2020-02-27
Date of Event2020-02-05
Date Mfgr Received2020-02-05
Device Manufacturer Date2019-01-09
Date Added to Maude2020-02-27
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 FDA3
Event Location3
Manufacturer ContactMGR. KATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9496801345
Manufacturer G1MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
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 NameMARATHON
Generic NameCATHETER, CONTINUOUS FLUSH
Product CodeKRA
Date Received2020-02-27
Returned To Mfg2020-02-13
Model Number105-5056
Lot NumberA764107
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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