• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number M0036126200
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 02/25/2021
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that when the subject coil was embolized, blood flow was stagnant due to deviation/migration of the subject coil loop from aneurysm to mother blood vessel and adhesion of thrombus occurred.Therefore, the stent was implanted at the a-com.At that time, an unknown guidewire was inserted to remove the catheter and collected together.When an unknown guidewire was removed, the coating of the unknown guidewire appeared on the lumen of the catheter.There was no health damage to the patient.No other information was provided.
 
Event Description
It was reported that when the subject coil was embolized, blood flow was stagnant due to deviation/migration of the subject coil loop from aneurysm to mother blood vessel and adhesion of thrombus occurred.Therefore, the stent was implanted at the a-com.At that time, an unknown guidewire was inserted to remove the catheter and collected together.When an unknown guidewire was removed, the coating of the unknown guidewire appeared on the lumen of the catheter.There was no health damage to the patient.No other information was provided.
 
Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.It was reported that during the procedure, blood flow was stagnant due to deviation/migration of the coil loop into the parent vessel and adhesion of thrombus occurred when the subject coil was embolized which required medical intervention (atlas stent implantation in the a-com).Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the tortuosity of the patient's anatomy was average.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TARGET XL 360 SOFT 6MM X 20CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key11564793
MDR Text Key242172943
Report Number3008881809-2021-00137
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613327004625
UDI-Public07613327004625
Combination Product (y/n)N
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/18/2023
Device Model NumberM0036126200
Device Catalogue NumberM0036126200
Device Lot Number22395232
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/26/2021
Initial Date FDA Received03/24/2021
Supplement Dates Manufacturer Received06/11/2021
Supplement Dates FDA Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATLAS STENT (STYKER); GUIDEWIRE (UNKNOWN MANUFACTURER); XT-17 CATHETER (STRYKER)
Patient Outcome(s) Other; Required Intervention;
-
-