MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 INTERMEDIATE CATHETER (132CM); CATHETER, THROMBUS RETRIEVER

Catalog Number	INC-11129-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product not yet received.
Event or Problem Description
It was reported that after the first pass with catheter while attempting to disconnect the tubing from catheter the catheter broke at the hub.The procedure was completed successfully.The patients medical condition was good.No clinical consequences were reported to the patient due to this event.
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 sample and it was observed the catheter was stuck in the non-stryker device and was stretched.When it was removed, it was broken.Dimensional inspection not required as the defect was visually confirmed.Functional could not be performed based on damage to product.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event was confirmed.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.The as reported catheter shaft break during use can be confirmed.The as reported/ as analyzed catheter shaft break during use as well as the as analyzed catheter shaft stretched will be assigned procedural factors as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
It was reported that after the first pass with catheter while attempting to disconnect the tubing from catheter the catheter broke at the hub.The procedure was completed successfully.The patients medical condition was good.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS VECTA 071 INTERMEDIATE CATHETER (132CM)
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 9351164
• Report Number: 3008853977-2019-00068
• Device Sequence Number: 14162322
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/31/2019

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 Catalogue Number: INC-11129-132
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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: ASPIRATION TUBING (UNKNOWN)