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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK XT-17 STANDARD STRAIGHT CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK XT-17 STANDARD STRAIGHT CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M003XC1775ST0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Hemorrhage, Subarachnoid (1893); Rupture (2208)
Event Date 12/30/2015
Event Type  Injury  
Manufacturer Narrative
This the 2nd of 2 reports: see mfr report # 3008880413-2018-00007. Subject device is not available.
 
Event Description
It was reported that stent-assisted coil embolization of an aneurysm located on the right mca (middle cerebral artery), a cerebral aneurysm rupture and sah (subarachnoid hemorrhage) occurred; the aneurysm was found to be at least 3 daughter sacs suggestive of previous sentinel bleeding. A catheter (subject device) was advanced over a guidewire but artery could not be accessed on second attempts due to an acute 90 degree angle. The ¿wire¿ flopped back into the aneurysm daughter sac and blood pressure was slight increase during the second attempt to catheterize the superior division. The angiographic image demonstrated contrast extravasation from the superior dome of the aneurysm. Medication (protamine) was administered immediately, a coil was carefully deployed to stop the bleeding, and an occlusion balloon catheter was immediately advanced and inflated to tamponade the right mca. The hemostasis was achieved within 7 minutes, and angiogram confirmed no further extravasation of contrast. The patient was not considered suitable by the site for stent assisted coiling, and was treated with 5 coils for embolization. The patient was assessed having mrs (modified rankin scale) of 1 post-procedure. According to physician aneurysm rupture occurred during second attempt of catheterization with the guidewire and subject microcatheter.
 
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Brand NameXT-17 STANDARD STRAIGHT
Type of DeviceCATHETER, PERCUTANEOUS
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 Key7308634
MDR Text Key101344009
Report Number3008881809-2018-00093
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2017
Device Catalogue NumberM003XC1775ST0
Device Lot Number18437962
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2018 Patient Sequence Number: 1
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