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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035422540
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolus (1830)
Event Date 12/05/2017
Event Type  Injury  
Manufacturer Narrative
The subject device is not available.
 
Event Description
During a coil embolization procedure, two coils could not be inserted into the hub of the microcatheter; the case was completed successfully using other coils.It was further reported that the patient had a distal emboli shown on his final angiogram and the physician was unsure if this was related to the coils.No further information is available.
 
Manufacturer Narrative
Product available to stryker; corrected to reflect the device is not available.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis, therefore physical and functional tests could not be performed.However, patient embolus is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.The subject device is not available.
 
Event Description
During a coil embolization procedure, two coils could not be inserted into the hub of the microcatheter; the case was completed successfully using other coils.It was further reported that the patient had a distal emboli shown on his final angiogram and the physician was unsure if this was related to the coils.No further information is available.
 
Manufacturer Narrative
Product available to stryker ¿ device was received, corrected to ¿return¿.The subject device was received.Analysis of the returned device found the delivery wire and the main coil were kinked/bent, and resistance was encountered in the sheath during functional testing.Based on device analysis and the information available, the damage to the device was likely the result of a deviation from directions for use (dfu), as reported by the user.There was no change to the investigation conclusion after device analysis as the reported patient embolus is a known risk associated with endovascular procedures and noted as such in the device dfu.Therefore, adverse event related to procedure was assigned to this event.
 
Event Description
During a coil embolization procedure, two coils could not be inserted into the hub of the microcatheter; the case was completed successfully using other coils.It was further reported that the patient had a distal emboli shown on his final angiogram and the physician was unsure if this was related to the coils.No further information is available.
 
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Brand Name
TARGET 360 ULTRA 2.5MM X 4CM
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 Key7159276
MDR Text Key96206355
Report Number3008881809-2018-00019
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K102672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue NumberM0035422540
Device Lot Number19676383
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2017
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 Outcome(s) Other;
Patient Age42 YR
Patient Weight80
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