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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 - 060X132 (FDA) CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK AXS CATALYST 6 - 060X132 (FDA) CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M003IC0601320
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 05/09/2016
Event Type  Injury  
Manufacturer Narrative
The subject device was disposed of at the hospital.
 
Event Description
It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment. During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage. No treatment was required and the outcome was reported as self-resolved. The patient was discharged home approximately three days later. The event was reported to be related to the procedure and unknown if related to the device.
 
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. From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event. However, hemorrhage is a known risk associated with endovascular procedures and is listed as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
 
Event Description
It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment. During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage. No treatment was required and the outcome was reported as self-resolved. The patient was discharged home approximately three days later. The event was reported to be related to the procedure and unknown if related to the device.
 
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Brand NameAXS CATALYST 6 - 060X132 (FDA)
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 CA NA
Manufacturer Contact
tara lopez
47900 bayside parkway
model farm road
fremont, CA 94538
5104132500
MDR Report Key5802950
MDR Text Key49838747
Report Number3008881809-2016-00079
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2018
Device Catalogue NumberM003IC0601320
Device Lot Number18821256
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 Received10/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2016
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: 07/19/2016 Patient Sequence Number: 1
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