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	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during a thrombectomy procedure, there was a catheter (subject device) kink that caused fracture of the distal segment.The physician had to snare the broken catheter and pull it out of the patient.According to the physician, the break was caused by a difficult anatomy.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during a thrombectomy procedure, there was a catheter (subject device) kink that caused fracture of the distal segment.The physician had to snare the broken catheter and pull it out of the patient.According to the physician, the break was caused by a difficult anatomy.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned device and it was observed that the catheter proximal shaft was kinked and compressed (flattened) distal to the strain relief.No anomalies were observed with the proximal lumen.Functional evaluation could not be performed due to the anomalies found on the catheter.Additional information provided by the customer indicated that the device was removed properly from the hoop and that the surgeon felt the patient's "difficult anatomy" contributed to the event.The reported separation could not be confirmed.As a result the cause code of not confirmed was assigned to the as reported catheter break.

• 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: 8676935
• Report Number: 3008853977-2019-00046
• Device Sequence Number: 2511344
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 13260-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/20/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 3 MAX REPERFUSION CATHETER (PENUMBRA INC); FATHOM GUIDEWIRE (BOSTON SCIENTIFIC)
• Outcome Attributed to Adverse Event: Required Intervention