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	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
During a case, the catheter (subject device) cracked at the proximal end.There were no clinical consequences to the patient.
Event or Problem Description
During a case, the catheter (subject device) cracked at the proximal end.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date: added.D10 product available to stryker: updated.H3 device evaluated by mfg: updated.H4 mfg date: added.H6 method code grid: updated.H6 results code grid: updated.H6 conclusion code grid: updated.The device history record review confirms that the device met all material, assembly, and performance specifications.Visual and microscopic examination of the returned device found that the catheter was separated distal to the strain relief.Functional testing could not be performed due to the anomalies found on the catheter.Based on the analysis, the reported event was confirmed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the investigation results and available information, it is possible that performance was limited due to procedural and/or anatomical factors during use.Therefore, a cause of procedural factors has been assigned to this investigation.

• 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: 8664418
• Report Number: 3008853977-2019-00044
• Device Sequence Number: 2130080
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: No Information
• Device Expiration Date: 08/07/2021
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 13222-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1