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 Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
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 separated distal to the strain relief and stretched.The catheter was also found to be slightly compressed on its distal tip.The reported event was confirmed based on the product analysis.The catheter appeared to have been kinked first then stretched and separated on its proximal shaft due to excessive manipulation during use.It is possible that the damage found on the distal tip was also due to handling.Therefore, a probable cause of handling damage has been assigned to this investigation.
Event or Problem Description
Analysis of the investigation found that the dac shaft was broken/fractured.There were no clinical consequences to the patient.

• 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: 8676929
• Report Number: 3008853977-2019-00047
• Device Sequence Number: 2349310
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 08/02/2021
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 13200-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1