MARKSMAN FA-55150-1030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for MARKSMAN FA-55150-1030 manufactured by Micro Therapeutics, Inc. Dba Ev3.

Event Text Entries

[183938333] The marksman catheter will not be returned for evaluation as it was discarded; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. Based on image provided there is evidence of marksman catheter separation. However, the cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183938334] Medtronic received a report that the medtronic flow diverter couldn't be pushed out of the marksman catheter. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right carotid artery c4-c5 segment with a max diameter of 13 mm and a 10 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. It was reported that there was resistance in the distal segment of the catheter, and the catheter became kinked. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. "based on review of customer-provided device images, there is evidence of marksman catheter separation and stretch. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00247
MDR Report Key9845254
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2019-07-27
Date Added to Maude2020-03-17
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. DBA EV3
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 NameMARKSMAN
Generic NameCATHETER, CONTINUOUS FLUSH
Product CodeKRA
Date Received2020-03-17
Model NumberFA-55150-1030
Lot Number218155355
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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