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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035476300
Device Problems Deformation Due to Compressive Stress (2889); Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
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.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, a cause of undeterminable has been assigned to this investigation.
 
Event Description
It was reported that during the procedure, the physician extracted the tip of the subject coil pusher wire and it was slightly kinked.This lead to further kinking during advancement of the subject coil in the micro catheter and incomplete detachment inside the patient anatomy.The physician removed the subject coil and replaced it successfully with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.The device was returned within a dispenser coil in the introducer sheath.The lot number was confirmed with the packaging returned with the device.During visual inspection, the proximal contact wire was intact.The coil delivery wire was kinked/bent.The main coil was returned attached to the delivery wire.The distal tip was found to be intact.The main coil was severely stretched.The suture was damaged.Main coil length could not be measured due to the condition of the returned device.No other anomalies were noted.During functional inspection, coil friction in introducer sheath test - fail.The device was flushed and advanced in the introducer sheath, there was resistance felt.The reported defect of main coil prematurely detached/separated inside patient was not confirmed.The reported defect of coil delivery wire kinked/bent was confirmed during analysis.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 main coil was returned attached to the delivery wire.As such, the as reported main coil prematurely detached/separated during use was not confirmed.The main coil was found to be severely stretched and the suture was damaged causing introducer sheath friction during analysis.Therefore, the as analyzed events will be assigned procedural factors as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this defect appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage will be assigned.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.
 
Event Description
It was reported that during the procedure, the physician extracted the tip of the subject coil pusher wire and it was slightly kinked.This lead to further kinking during advancement of the subject coil in the micro catheter and incomplete detachment inside the patient anatomy.The physician removed the subject coil and replaced it successfully with a new device and continued the procedure without clinical consequences to the patient.
 
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Brand Name
TARGET 360 SOFT 6MM X 30CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key9276225
MDR Text Key165480690
Report Number3008881809-2019-00333
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2022
Device Catalogue NumberM0035476300
Device Lot Number21199591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Date Manufacturer Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR SL-10 (STRYKER)
Patient Age45 YR
Patient Weight65
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