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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 125CM - CE; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 125CM - CE; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number IC068125A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2023
Event Type  malfunction  
Event Description
It was reported that during mca (middle cerebral artery) m1 occlusion case, when removing the subject catheter from the anatomy difficulty was encountered and the subject catheter tail (shaft) was fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During a visual inspection, the catheter shaft was found to be broken/fractured, the un-known silicone tube was attached to the broken proximal end of the catheter, and the catheter shaft was found to be kinked/bent.During a functional inspection, catheter shaft broken/fractured during use functional test is not available as the defect was confirmed during visual inspection.And catheter shaft difficulty removing/withdrawing functional test was unable to perform due to condition of the device.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 reported catheter shaft broken/fractured during was confirmed during the analysis.The reported catheter shaft difficulty removing/withdrawing could not be confirmed/duplicated; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.During the analysis the catheter shaft was seen to be broken/fractured, therefore, the s reported 'catheter shaft broken/fractured during use' was confirmed.An assignable cause of procedural factors will be assigned to as reported and as analyzed code, 'catheter shaft broken/fractured during use', the as reported code, 'catheter shaft difficulty removing/withdrawing' as well as the analyzed code 'catheter shaft kinked/bent', as this complaint appears 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 factors during use.
 
Event Description
It was reported that during mca (middle cerebral artery) m1 occlusion case, when removing the subject catheter from the anatomy difficulty was encountered and the subject catheter tail (shaft) was fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
AXS CATALYST 7 .068IN ID X 125CM - CE
Type of Device
CATHETER, THROMBUS RETRIEVER
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 Key16737808
MDR Text Key313321725
Report Number3008881809-2023-00187
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K183464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIC068125A
Device Lot Number23771686
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2023
Initial Date FDA Received04/13/2023
Supplement Dates Manufacturer Received05/02/2023
Supplement Dates FDA Received05/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
5F MPA CATHETER (NON-STRYKER); 6F LONG SHEATH (UNKNOWN MANUFACTURER); GUIDEWIRE (UNKNOWN MANUFACTURER); REBAR-18 MICROCATHETER(NON-STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER); TREVO STENT (STRYKER)
Patient Age88 YR
Patient SexFemale
Patient RaceAsian
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