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

Model Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned and the reported lot number was confirmed from the returned device.Visual/microscopic inspection revealed that the catheter shaft was broken at 54 mm from the proximal end of the hub (adjacent to the strain relief).Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 analysed event.As per the available information, the device was damaged being pushed through the balloon catheter.The reported event was confirmed based on the damage noted during analysis.An assignable cause of procedural factors was assigned to the as reported "catheter shaft kinked/bent" and the as analysed "catheter shaft broken/fractured inside patient/during use", 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.
Event or Problem Description
The subject catheter was returned for analysis and it was discovered that the subject catheter shaft was broken/fractured inside the patient's anatomy during procedure.The procedure was completed successfully using a new catheter.There were no reported clinical consequences to the patient.

• 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 ; IE NA
• MDR Report Key: 10174957
• Report Number: 3008881809-2020-00179
• Device Sequence Number: 16759662
• 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): 06/19/2020

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: 07/15/2021
• Device Model Number: IC068132
• Device Catalogue Number: IC068132
• Device Lot Number: 21601826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1