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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035478300
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
The subject device is not available.
 
Event Description
During the stent assisting coil embolization procedure for an aneurysm, it was reported that big resistance was encountered when advancing the 9th coil in the microcatheter.So the physician withdraw the coil and found it was stretched and fractured.Then the whole coil was removed from the patient and the procedure was completed successfully after changing to another coil.The patient¿s condition was reported to be good.
 
Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the delivery wire was kinked due to handling damage and the main coil was prematurely detached inside the patient.In addition, the delivery wire detachment zone was inspected, and the main coil appears to have detached due to a physical break.The functioning test could not be performed due to the condition of the returned device.Additional information indicates that no anomalies were noted to the device prior to use and there is no indication of a use error.The device is likely to have been damaged during use resulting in the reported events.An assignable cause of cause traced to component failure will be assigned to the as reported event and to the as analyzed defect on the main coil.As the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
During the stent assisting coil embolization procedure for an aneurysm, it was reported that big resistance was encountered when advancing the 9th coil in the microcatheter.So the physician withdraw the coil and found it was stretched and fractured.Then the whole coil was removed from the patient and the procedure was completed successfully after changing to another coil.The patient¿s condition was reported to be good.
 
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Brand Name
TARGET 360 SOFT 8MM X 30CM
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 Key8205262
MDR Text Key131713559
Report Number3008881809-2018-00556
Device Sequence Number1
Product Code HCG
UDI-Device Identifier04546540676603
UDI-Public04546540676603
Combination Product (y/n)N
Reporter Country CodeCN
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 02/25/2019
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 Date06/18/2021
Device Catalogue NumberM0035478300
Device Lot Number20622992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2018
Initial Date FDA Received12/29/2018
Supplement Dates Manufacturer Received01/30/2019
Supplement Dates FDA Received02/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age69 YR
Patient Weight75
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