MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the catheter (subject device) was broken/fractured during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated (manufacturing execution system) mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned in a looped, twisted and knotted condition.The catheter was seen to be kinked towards the distal end of the catheter and was fractured at 1cm from the catheter hub.There were no damages noted to the catheter hub or tip.Functional testing was not performed as the defect was confirmed visually.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 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 patient's anatomy was noted to be tortuous and there were no broken fragments left inside the patient.During the analysis, the catheter shaft was seen to be kinked towards the distal end of the catheter, therefore the as reported can be confirmed.The catheter shaft was seen to be fractured near the hub.There were no damages noted to the catheter hub.The device was returned in an over looped, tied condition, due to which it become difficult to decide whether the analyzed defect occurred during the procedure or while preparing the device to send back for analysis after procedure.However, since the kink/bent was reported during the procedure, it is possible that the catheter shaft broke during the procedure.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the catheter shaft kinked/bent and the analyzed code of catheter shaft broken/fractured during use as these issues are 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 and/or anatomical factors during use.

• Brand Name: AXS CATALYST 7 .068IN 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: 18853005
• Report Number: 3008881809-2024-00093
• Device Sequence Number: 20616192
• Product Code: NRY
• UDI-Device Identifier: 07613327417227
• UDI-Public: 07613327417227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183464
• 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
• Report Date (Section B): 03/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2024
• Device Catalogue Number: IC068132
• Device Lot Number: 23942951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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
• Patient Sex: Unknown