MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 ASPIRATION CATHETER (132CM); CATHETER, THROMBUS RETRIEVER

Catalog Number	INC-11597-132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the catheter was broken near the hub when advanced through the patient's anatomy.Another catheter was used to complete the procedure.There were no clinical consequences to the patient as a result of this event.
Event or Problem Description
It was reported that when the catheter was broken near the hub when advanced through the patient's anatomy.Another catheter was used to complete the procedure.There were no clinical consequences to the patient as a result of this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the catheter proximal shaft was found kinked and was separated just distal to the strain relief.Functional testing was not performed due to the anomalies noted to the catheter.In case of this complaint, visual inspection of the fractured site indicates that the catheter was kinked first and then separated due to excessive manipulation.As a result, a probable cause of handling damage was assigned to the reported and an analyzed event catheter shaft broken inside patient.

• Brand Name: AXS VECTA 074 ASPIRATION CATHETER (132CM)
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8454454
• Report Number: 3008853977-2019-00024
• Device Sequence Number: 2988890
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/14/2019

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 Expiration Date: 01/21/2022
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 13732-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1