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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET XXL 360 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0036181240
Device Problem Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Manufacturer Narrative
H3 other text : the device remains implanted in the patient.
 
Event Description
It was reported that during coil embolization procedure, the operator delivered the microcatheter into the splenic artery aneurysm.After one coil was placed, the subject coil was delivered and part of it was placed into aneurysm.However, when the subject coil was pulled back for repositioning, it prematurely detached.The remaining subject coil was pushed into the aneurysm by flushing.After this four more coils were placed into aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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.Visual and functional investigations were not conducted as the device was implanted in the patient¿s anatomy and was not returned.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
 
Event Description
It was reported that during coil embolization procedure, the operator delivered the microcatheter into the splenic artery aneurysm.After one coil was placed, the subject coil was delivered and part of it was placed into aneurysm.However, when the subject coil was pulled back for repositioning, it prematurely detached.The remaining subject coil was pushed into the aneurysm by flushing.After this four more coils were placed into aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
TARGET XXL 360 12MM X 45CM
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 Key18990379
MDR Text Key338936478
Report Number3008881809-2024-00130
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613327128307
UDI-Public07613327128307
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161429
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 05/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM0036181240
Device Lot Number24306638
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2023
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
MICROCATHETER (UNKNOWN).; TARGET COIL (STRYKER).
Patient Age71 YR
Patient SexMale
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