MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 ASPIRATION CATHETER (132CM); CATHETER, THROMBUS RETRIEVER

Catalog Number	INC-11129-132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that the aspiration catheter was fractured at the hub.The procedure was successfully completed with no clinical consequences to the patient.
Additional Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use and continuous flush was set up and maintained throughout the procedure as per the dfu (direction for use).Based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that the aspiration catheter was fractured at the hub.The procedure was successfully completed with no clinical consequences to the patient.

• Brand Name: AXS VECTA 071 ASPIRATION CATHETER (132CM)
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8800172
• Report Number: 3008853977-2019-00057
• Device Sequence Number: 14271033
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• 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): 07/24/2019

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 Catalogue Number: INC-11129-132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1