MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 INTERMEDIATE CATHETER (115CM); CATHETER, THROMBUS RETRIEVER

Catalog Number	INC-11129-115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during combination thrombectomy pull, the subject device catheter was fractured at the proximal and it appears to also have unraveled.All pieces were successfully removed, and the procedure was completed successfully with other distal access catheter products.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The catheter was returned with a wire inserted and could not be removed.The device was examined, and it was found to be broken and stretched on the catheter shaft.In addition, the catheter was compressed.Functional testing could not be performed due to the condition of the returned device.Additional information provided by the customer indicated that the patient's anatomy was moderately tortuous, continuous flush was maintained throughout the procedure, and the catheter initially could not track into the intended position.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the device directions for use (dfu), but performance was limited due to procedural factors during use.Therefore, a cause of 'procedural factors' has been assigned to this investigation.
Event or Problem Description
It was reported that during combination thrombectomy pull, the subject device catheter was fractured at the proximal and it appears to also have unraveled.All pieces were successfully removed, and the procedure was completed successfully with other distal access catheter products.There were no clinical consequences to the patient due to the reported event.

• Brand Name: AXS VECTA 071 INTERMEDIATE CATHETER (115CM)
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8919119
• Report Number: 3008853977-2019-00060
• Device Sequence Number: 19290009
• Product Code: NRY
• UDI-Device Identifier: 07613327459210
• UDI-Public: 07613327459210
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/05/2019

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: 10/24/2021
• Device Catalogue Number: INC-11129-115
• Device Lot Number: 13494-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALYST 6 DEVICES (STRYKER)