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

Catalog Number INC-11129-132

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that when the catheter was removed from the dispenser hoop, the catheter shaft was cracked, and saline was squirting out of the catheter shaft.Another catheter was used to complete the procedure.There were no clinical consequences to the patient as a result of this event.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, additional information from the customer indicated that the no damage was noted to the packaging, no other anomalies were noted to the device during preparation, the catheter was removed from the plastic clip on the packaging by lifting it up and the crack on the catheter was found on the section that was inside the hoop.The procedure was completed successfully using a new device and there was no medical intervention or adverse consequences to the patient as a result of this event.It is possible that during the device preparation, force may have been exerted on the catheter while removing it from the hoop, which may have caused the crack at mid-shaft.However, based on the review of the available information, that cannot be definitively determined and since the device was not returned for analysis, an assignable cause of undetermined was assigned to the as reported issues 'nv - catheter shaft leak' and 'nv - catheter shaft damaged'.Expiration date: added.Manufacturing date: added.

Event Description

It was reported that when the catheter was removed from the dispenser hoop, the catheter shaft was cracked, and saline was squirting out of the catheter shaft.Another catheter was used to complete the procedure.There were no clinical consequences to the patient as a result of this event.

• Brand Name: AXS VECTA 071 ASPIRATION CATHETER (132CM)
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8215646
• MDR Text Key: 132068696
• Report Number: 3008853977-2019-00004
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (y/n): N
• PMA/PMN Number: K172167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2021
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 13201-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1