MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 046 CATH 146CM - US; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Catalog Number	INC-11814-146
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual inspection was performed as the shaft of the subject catheter was kinked.The catheter shaft was seen to be broken/fractured 32 cm from the hub.Functional testing could not be performed due to the condition of the returned subject device.The reported 'catheter shaft kinked/bent' was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device directions for use (dfu).As well, 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.During analysis, the shaft of the subject catheter was seen to be kinked/bent.The catheter shaft was seen to be broken/fractured 32 cm form the hub.Based on the available information and condition of returned condition, it is probable that the rotating hemostatic valve (rhv) was not adequately loosened during the retrieval attempt, which may have increased frictional resistance on the catheter shaft.Furthermore, it is also probable that the tortuous anatomy, might have further increased the resistance encountered during use, making the device more susceptible to internal damage under tension.An assignable cause of procedural factors will be assigned to the as reported 'catheter shaft kinked/bent' as well as analyzed ' catheter shaft broken/fractured during use¿ as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
The subject device was returned for analysis, and it was discovered that the shaft of the subject device was broken/fractured during use.The procedure was reported to be completed successfully.No clinical consequences were reported to the patient.

• Brand Name: AXS VECTA 046 CATH 146CM - US
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 25611679
• Report Number: 3008853977-2026-00014
• Device Sequence Number: 12142696
• Product Code: QJP
• UDI-Device Identifier: 07613327519365
• UDI-Public: (01)07613327519365(17)280811(10)28053-01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202752
• 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): 06/24/2026

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-11814-146
• Device Lot Number: 28053-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown