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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2.5 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2.5 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035452560
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2014
Event Type  malfunction  
Event Description
It was reported that friction was noted when attempting to introduce a coil (subject device) into a microcatheter, and the coil was found to be detached after removal from the patient.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
The subject device was not returned.
 
Event Description
It was reported that friction was noted when attempting to introduce a coil (subject device) into a microcatheter, and the coil was found to be detached after removal from the patient.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 device was returned for analysis and the proximal contact section was kinked, which is likely related to handling damage during use.The main coil appeared to have broken from the delivery wire at the detachment zone.The main coil was not returned.No anomalies were noted to the introducer sheath.Review and analysis of available information failed to identify a definitive cause for the observed break.
 
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Brand Name
TARGET HELICAL NANO 2.5 MM X 6 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
alyson harris
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key4322649
MDR Text Key5132860
Report Number3008853977-2014-00392
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 11/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2017
Device Catalogue NumberM0035452560
Device Lot Number17718618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2015
Initial Date FDA Received12/11/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2014
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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