TARGET HELICAL ULTRA 2MM X 8CM M0035432080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for TARGET HELICAL ULTRA 2MM X 8CM M0035432080 manufactured by Stryker Neurovascular Cork.

Event Text Entries

[184509303] The device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[184509304] It was reported that after the coil (subject device ) was placed inside the aneurysm, it was attempted to be detached 5 times without success. During retraction of the coil delivery wire, the subject coil prematurely detached, placed inside the parent artery, and was managed to be placed back at the target site by pushing with the microcatheter and guidewire. The procedure was completed successfully without clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008881809-2020-00068
MDR Report Key9865530
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-23
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 ContactMR. TARA LOPEZ
Manufacturer Street47900 BAYSIDE PARKWAY
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal94538
Manufacturer Phone5104132500
Manufacturer G1STRYKER NEUROVASCULAR CORK
Manufacturer StreetIDA INDUSTRIAL ESTATE MODEL FARM ROAD
Manufacturer CityCORK NA
Manufacturer CountryIE
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTARGET HELICAL ULTRA 2MM X 8CM
Generic NameDEVICE, NEUROVASCULAR EMBOLIZATION
Product CodeHCG
Date Received2020-03-23
Model NumberM0035432080
Catalog NumberM0035432080
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER NEUROVASCULAR CORK
Manufacturer AddressIDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA IE NA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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