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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 .058IN ID X 115CM - CE; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR CORK AXS CATALYST 5 .058IN ID X 115CM - CE; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M003IC058115A0
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Event Description
It was reported that flow diverter stent placement was performed for ica clinoid segment multiple aneurysms.The patient is reported to have had moderately tortuous vascular anatomy.During the procedure the subject distal access catheter was placed at the beginning of the middle cerebral artery, but when a flow diverter stent was delivered together with a guidewire in the subject distal access catheter, the stent could not be delivered past the oa (ophthalmic artery) segment (c6 segment of internal carotid artery).Then the physician found that the guidewire which was used together with the subject distal access catheter was going out from the distal part of the catheter.The physician suspected there to have been a break or perforation on the subject catheter tip.As a result, the operator withdrew all devices and checked to see whether the distal of the subject distal access catheter was broken/perforated.There was no damage noted to the guidewire and the stent delivery catheter.The physician replaced the subject catheter and stent with similar devices and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Event Description
It was reported that flow diverter stent placement was performed for ica clinoid segment multiple aneurysms.The patient is reported to have had moderately tortuous vascular anatomy.During the procedure the subject distal access catheter was placed at the beginning of the middle cerebral artery, but when a flow diverter stent was delivered together with a guidewire in the subject distal access catheter, the stent could not be delivered past the oa (ophthalmic artery) segment (c6 segment of internal carotid artery).Then the physician found that the guidewire which was used together with the subject distal access catheter was going out from the distal part of the catheter.The physician suspected there to have been a break or perforation on the subject catheter tip.As a result, the operator withdrew all devices and checked to see whether the distal of the subject distal access catheter was broken/perforated.There was no damage noted to the guidewire and the stent delivery catheter.The physician replaced the subject catheter and stent with similar devices and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal section of the catheter was noted to be kinked and there was deformation noted to the distal end of the catheter at the distal tip.During functional inspection, patency test was passed.The catheter was flushed, and a leak was noted through the deformed section of the catheter.The reported complaint was confirmed based on product analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The analysed 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 analyzed event.It was reported that the catheter was perforated when advancing the surpass streamline flow diverter system.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, continuous flush set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The device was returned and it was confirmed to be kinked/ deformed and perforated.The returned surpass streamline delivery catheter was noted to be deformed.It is probable that the device was damaged during navigation of the surpass streamline delivery system causing the reported perforation and the damage noted during analysis.An assignable cause of procedural factors will be assigned to the reported and to the analyzed events as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
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Brand Name
AXS CATALYST 5 .058IN ID X 115CM - CE
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key12320564
MDR Text Key266472467
Report Number3008881809-2021-00334
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K151667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2022
Device Catalogue NumberM003IC058115A0
Device Lot Number22550970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NEURON MAX 088 (PENUMBRA); SURPASS STREAMLINE 4.0MM X 20MM - CE (STRYKER); SYNCHRO 0.014IN 200CM GUIDEWIRE (STRYKER); NEURON MAX 088 (PENUMBRA); SURPASS STREAMLINE 4.0MM X 20MM - CE (STRYKER); SYNCHRO 0.014IN 200CM GUIDEWIRE (STRYKER)
Patient Age65 YR
Patient Weight69
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