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	06/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thrombectomy procedure, the subject catheter fractured on the proximal end.The physician replaced it with a new catheter and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during a thrombectomy procedure, the subject catheter fractured on the proximal end.The physician replaced it with a new catheter and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date: added.H3 device evaluated by mfg: updated.H3 summary attached: updated.H4 manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that catheter was kinked, stretched and separated.The functional evaluation could not be performed due to the anomalies found on the device.Additional information provided by the customer indicated that the device was inspected and confirmed to be in good condition during/after unpacking, continuous flush was set up and maintained throughout the procedure, and the break was noticed during advancement of the subject device into the base guide catheter.Based on visual inspection, the catheter appeared to have been kinked first and then stretched and separated due to excessive force applied at the proximal end during use.As a result, a probable cause of handling damage has been assigned to the reported event and analyzed anomalies.

• 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: 8799927
• Report Number: 3008853977-2019-00056
• Device Sequence Number: 16900910
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/11/2019

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: 08/31/2021
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 13321-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: NEURON MAX LONG SHEATH (NON-STRYKER); SYNCHRO GUIDEWIRE (STRYKER); NEURON MAX LONG SHEATH (NON-STRYKER); SYNCHRO GUIDEWIRE (STRYKER)