MAUDE Adverse Event Report: STRYKER NEUROVASCULAR STRYKER AXS CATALYST 5; CATHETER, PERCUTANEOUS

Model Number	M0031C0581150
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Tip of catheter broke of during neuro intervention treatment causing loss of blood flow to brain arteries.Fda safety report id# (b)(4).

• Brand Name: STRYKER AXS CATALYST 5
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 11064784
• Report Number: MW5098494
• Device Sequence Number: 19723064
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: (01)07613327012019(17)220607(10)
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2020

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: 06/07/2020
• Device Model Number: M0031C0581150
• Device Catalogue Number: IC058115
• Device Lot Number: 22312232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Disability
• Patient Age: 63 YR