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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number M0035431030
Device Problem Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2022
Event Type  malfunction  
Event Description
It was reported during the aneurysm embolization, the subject coil detached unexpectedly and got stuck in microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported during the aneurysm embolization, the subject coil detached unexpectedly and got stuck in microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.  during visual/microscopic inspection, the coil delivery wire kinked/bent.The main coil was found to be detached/separated.  functional testing was not applicable.  the reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The product was returned.During analysis, the coil delivery wire was found to be kinked/bent and detached.An assignable cause of procedural factors will be assigned to 'main coil prematurely detached/separated during use' as these defects are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.
 
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Brand Name
TARGET HELICAL NANO 1MM X 3CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI   NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key16058114
MDR Text Key308206122
Report Number3008881809-2022-00654
Device Sequence Number1
Product Code HCG
UDI-Device Identifier04546540698018
UDI-Public04546540698018
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2023
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 Model NumberM0035431030
Device Catalogue NumberM0035431030
Device Lot Number23570019
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2022
Initial Date FDA Received12/28/2022
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received02/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SL-10 MICROCATHETER (STRYKER).
Patient Age64 YR
Patient SexMale
Patient RaceAsian
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