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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number M0035425100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2023
Event Type  Injury  
Event Description
It was reported that during an embolization procedure, when the subject coil was placed.The subject coil became stretched after repositioned several times and the snare was used to retrieve it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
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.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.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.Information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use and was used as per the dfu.The coil appears to have stretched after repositioning multiple times.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 event of 'main coil stretched' and 'patient medical or surgical intervention required'.
 
Event Description
It was reported that during an embolization procedure, when the subject coil was placed.The subject coil became stretched after repositioned several times and the snare was used to retrieve it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
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Brand Name
TARGET 360 ULTRA 5MM X 10CM
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 Key17331462
MDR Text Key319091619
Report Number3008881809-2023-00355
Device Sequence Number1
Product Code HCG
UDI-Device Identifier04546540675958
UDI-Public04546540675958
Combination Product (y/n)N
Reporter Country CodeJA
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 11/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM0035425100
Device Catalogue NumberM0035425100
Device Lot Number23791995
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2022
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
GOOSENECK SNARE (UNKNOWN); UNKNOWN MICROCATHETER
Patient Outcome(s) Required Intervention;
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