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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035453060
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
The subject device is not available.
 
Event Description
It was reported that during the coil embolization procedure, the coil detached prematurely.The detached coil was safely retrieved from the patient.There were no clinical consequences to the patient reported.
 
Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The main coil was the only part of the device returned for analysis, therefore, inspection of the delivery wire etc cannot take place.Analysis of the returned device revealed that the main coil was kinked bent.The main coil junction was broken and based on the microscopic analysis, it was physically damaged.There seems to be kinked/bent sections near the main coil junction which may indicate that there was force applied to the device which could have in turn caused the detachment.Functional testing could not be performed as the delivery wire was not returned with the coil.It is probable that the damage was sustained to the device during the clinical procedure limiting the performance of the device during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
 
Event Description
It was reported that during the coil embolization procedure, the coil detached prematurely.The detached coil was safely retrieved from the patient.There were no clinical consequences to the patient reported.
 
Manufacturer Narrative
Expiration date: added.Manufacturing date: added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.Based on the information available the exact cause for the reported event cannot be determined.
 
Event Description
It was reported that during the coil embolization procedure, the coil detached prematurely.The detached coil was safely retrieved from the patient.There were no clinical consequences to the patient reported.
 
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Brand Name
TARGET HELICAL NANO 3 MM X 6 CM
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 Key7274069
MDR Text Key100249630
Report Number3008881809-2018-00079
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K113412
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue NumberM0035453060
Device Lot Number19957846
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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