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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035423100
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2018
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that when the coil was advanced in the microcatheter, the coil detached prematurely inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the delivery wire was broken/fractured and the main coil was kinked.Functional testing could not be performed due to the damaged condition of the returned coil.Device analysis revealed that the main coil had not detached as originally reported, but the coil delivery wire was broken.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.
 
Event Description
It was reported that when the coil was advanced in the microcatheter, the coil detached prematurely inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
 
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Brand Name
TARGET 360 ULTRA 3MM X 10CM
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 Key7594795
MDR Text Key110853853
Report Number3008881809-2018-00258
Device Sequence Number1
Product Code HCG
UDI-Device Identifier04546540675903
UDI-Public04546540675903
Combination Product (y/n)N
Reporter Country CodeIN
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 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Catalogue NumberM0035423100
Device Lot Number20137766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
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 Age71 YR
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