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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 1CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 1CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035431010
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2016
Event Type  malfunction  
Manufacturer Narrative
The subject device is not available.
 
Event Description
It was reported that the coil was inserted into the microcatheter without flushing and air bubbles were formed in the rhv (rotating hemostatic valve) of the microcatheter.There were no consequences to the patient.
 
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Brand Name
TARGET HELICAL NANO 1MM X 1CM
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
sanda dracic
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key5903908
MDR Text Key52990050
Report Number3008881809-2016-00146
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K113412
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM0035431010
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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