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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035442540
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that when the coil (subject device) was advanced in the microcatheter, the coil got stuck and was detached prematurely.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that a prowler microcatheter with an internal diameter of 0.021" was used.Per the device dfu: "target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in])." it is likely that the incompatible microcatheter contributed to the damage noted to the device.Based on the information available, an assignable cause of use error was assigned to this event.
 
Event Description
It was reported that when the coil (subject device) was advanced in the microcatheter, the coil got stuck and was detached prematurely.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
 
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Brand Name
TARGET 360 NANO 2.5 MM X 4 CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key7366184
MDR Text Key103519311
Report Number3008881809-2018-00133
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Catalogue NumberM0035442540
Device Lot Number20101504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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