MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 .058IN ID X 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number	M003IC0581320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject catheter broke off during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported "i would like to file a complaint for two catheters that broke clean off during a case.No patient was hurt during the case and both were noticed broken once outside of body." additional information received from the customer indicated continuous flush was maintained throughout the clinical procedure.The extent of anatomical tortuosity is not known.The procedure was an aspiration case in the a1 segment.The dispenser hoop was flushed prior to removing the catheter.Upon removal from the patient after first pass, the cat 7 catheter was found to be fractured directly below the hub, with the fracture appearing to be a laser-type cut.The operator then switched to a cat 5 catheter.The same fracture event occurred with the cat 5.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported code 'catheter shaft broken/fractured during use'.
Event or Problem Description
It was reported that the subject catheter broke off during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS CATALYST 5 .058IN ID X 132CM - US
• Common Device Name: 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 Key: 23155461
• Report Number: 3008881809-2025-00521
• Device Sequence Number: 10154754
• Product Code: NRY
• UDI-Device Identifier: 07613327011999
• UDI-Public: (01)07613327011999(17)270622(10)25665748
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: M003IC0581320
• Device Lot Number: 25665748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST CATHETER (STRYKER).
• Patient Sex: Unknown