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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - CE VASCULAR GUIDE CATHETER

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STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - CE VASCULAR GUIDE CATHETER Back to Search Results
Catalog Number M003IC060132A0
Device Problem Fracture (1260)
Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative

The device is not available to the manufacturer.

 
Event Description

It was reported that during a mechanical thrombectomy procedure, resistance was noted approximately 10cm from the distal tip of the subject catheter. The patient had moderate vessel tortuosity. It was noted that the subject microcatheter distal tip had fractured within ica (internal carotid artery) vessel at first aspiration. Physician was unable to remove fragmented piece using additional stent retriever and left fragmented piece within patient. The patient previously had infarcts developing in the aca (anterior cerebral artery) and mca (middle cerebral artery) areas. The aca area infarcts may be due to the unretrieved broken catheter tip in the vessel, but this was not confirmed. No other information was provided.

 
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Brand NameAXS CATALYST 6 .060IN ID X 132CM - CE
Type of DeviceVASCULAR GUIDE CATHETER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10305554
MDR Text Key199838257
Report Number3008881809-2020-00214
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFI
PMA/PMN NumberK183463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberM003IC060132A0
Device LOT Number22224105
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2020
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: 07/21/2020 Patient Sequence Number: 1
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