MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 - 058X115 (FDA); CATHETER, PERCUTANEOUS

Catalog Number	M003IC0581150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the shaft was broken/ fractured at the junction between the grilamid sleeve and the catheter shaft.The catheter shaft was also kinked at 43cm from the proximal end, likely due to handling.Functional testing could not be performed due to the condition of the returned device.It is probable that the catheter shaft was broken/ fractured at the proximal end during removal from the dispenser hoop.However, based on the information currently available a definitive cause of the observed catheter shaft break could not be determined; therefore, an assignable cause of undeterminable was assigned.
Event or Problem Description
Analysis of the returned device noted that the catheter shaft was broken.No consequences to the patient were reported.

• Brand Name: AXS CATALYST 5 - 058X115 (FDA)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7676372
• Report Number: 3008881809-2018-00302
• Device Sequence Number: 16532556
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: 07613327012019
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151667
• 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): 07/10/2018

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: 11/30/2018
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 19442037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1