Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - CE; CATHETER, THROMBUS RETRIEVER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - CE; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number IC068132A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported during the procedure that the subject aspiration catheter kinked itself while being used along with a balloon catheter.It was then found to be broken/fractured in two parts during use.No further information is available.
 
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
Event Description
It was reported during the procedure that the subject aspiration catheter kinked itself while being used along with a balloon catheter.It was then found to be broken/fractured in two parts during use.No further information is available.
 
Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 / h3 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that the subject catheter was returned in two fragments (57cm proximal end, 75cm distal end) and was seen to be kinked.There was an additional break on the subject catheter shaft approximately 6cm from the hub.There was no damage noted to the subject catheter tip or hub.Functional testing was not required as the damage was confirmed through visual inspection.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 event catheter shaft broken/fractured during use and catheter kinked/bent was confirmed during analysis.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 there was no damage noted to the packaging prior to opening the packaging.It was reported the subject catheter kinked itself while being inserted into the balloon catheter device.The customer also stated that the subject catheter had a protruding metal spiral (this is just the make-up of the device so when the catheter shaft broke the inner coil was visible.) during analysis the subject catheter was returned in two fragments (57cm proximal end, 75cm distal end).There was a kink seen on the subject catheter shaft.There was an additional break 6cm from the catheter hub.No other anomalies noted.An assignable cause of procedural factors will be assigned to the as reported and as analyzed catheter shaft broken/fractured during use and catheter kinked/bent 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AXS CATALYST 7 .068IN ID X 132CM - 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 Key18593561
MDR Text Key333898828
Report Number3008881809-2024-00031
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeGM
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 03/20/2024
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 NumberIC068132A
Device Lot Number23928273
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2024
Initial Date FDA Received01/29/2024
Supplement Dates Manufacturer Received02/27/2024
Supplement Dates FDA Received03/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2022
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
FLOWGATE2 BALLOON CATHETER (STRYKER)
-
-