MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 .058IN ID X 115CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number	M003IC0581150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the catheter (subject device) tip was broken off in the patient.It was successfully removed with a retriever.The procedure was aborted and delayed by a week due to patient illness.No further information is available.
Event or Problem Description
It was reported that during the procedure the catheter (subject device) tip was broken off in the patient.It was successfully removed with a retriever.The procedure was aborted and delayed by a week due to patient illness.No further information is available.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the subject catheter shaft was kinked/bent 6cm from the proximal end of the proximal shaft.The catheter shaft was broken /fractured 117.8cm from the proximal end of the proximal shaft.The distal shaft was damaged.The catheter hub was intact.The fractured part of the shaft was not returned.The functional inspection was not required as the defect was confirmed.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported "the catheter (in case) had the tip break off in the patient.".Additional information received from the customer indicated the broken catheter tip was removed with a tiger retriever and aspiration.The catheter was confirmed to be in good condition prior to the procedure.The event occurred advancing the system to the area of interest.Did an angiogram and noticed the tip was broken off.There was mild tortuosity when advancing the system to the area of interest.During analysis, the catheter shaft was kinked/bent 6cm from the proximal end of the proximal shaft.The catheter shaft was broken /fractured 117.8cm from the proximal end of the proximal shaft.The distal shaft was damaged.The fractured part of the shaft was not returned.Based on the review of all available information and the analysis of the returned device, it appears that certain procedural factors may have influenced the occurrence of this event.The as reported 'catheter tip broken/fractured during use' as well as the as analysed ' catheter shaft kinked/bent', 'catheter tip broken/fractured during use' and 'catheter shaft damaged' will be assigned procedural factors 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.

• Brand Name: AXS CATALYST 5 .058IN ID X 115CM - 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: 23300907
• Report Number: 3008881809-2025-00555
• Device Sequence Number: 21339209
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: (01)07613327012019(17)270428(10)25593731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 25593731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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: RETIREVER (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown