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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0036125150
Device Problem Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  Injury  
Event Description
It was reported during the procedure the subject coil detached while repositioning inside the catheter.The catheter hub was cut and snare device was used to remove the subject coil from the catheter.The device was replaced and the procedure was completed successfully with no adverse consequences to the patient.
 
Manufacturer Narrative
H3 other text : device not returned for evaluation.
 
Manufacturer Narrative
B5 executive summary - updated.H4 manufacturing date ¿ added.D4 expiration date - added.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, visual and functional testing as well as physical analysis 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.The physician reported that the coil prematurely detached during repositioning the subject coil.The detachment system was not yet being used at the time of the premature detachment so it is likely that the coil physically detached due to a break.However as the coil has not been returned this cannot be confirmed.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 the reported event of the main coil prematurely detached during use and coil in catheter friction.
 
Event Description
It was reported during the procedure the subject coil detached while repositioning inside the catheter.The catheter hub was cut and snare device was used to remove the subject coil from the catheter.The device was replaced and the procedure was completed successfully with no adverse consequences to the patient.Update: it was reported during the procedure the subject coil detached in the vessel.The catheter hub was cut and snare device was used to remove the subject coil.The device was replaced, and the procedure was completed successfully with no adverse consequences to the patient.
 
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Brand Name
TARGET XL 360 SOFT 5MM X 15CM
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 Key18983416
MDR Text Key338643872
Report Number3008881809-2024-00125
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613327128291
UDI-Public07613327128291
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 05/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM0036125150
Device Lot Number24299685
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2023
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
SL-10 CATHETER (STRYKER)
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient SexFemale
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