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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter (subject device) was used in the thrombectomy procedure.However, the physician was unable to aspirate the thrombus as the subject device was felt to be leaking near shaft.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
D4 ¿ expiration date ¿ added.D4 ¿ gtin ¿ updated.D9 - product available to stryker - updated.D9 - returned to manufacturer on ¿ updated.H3 - device evaluated by mfg ¿ updated.H4 ¿ manufacturing date - added.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the catheter was returned with tegaderm dressing attached to it.The catheter shaft was found to be broken/fractured.The catheter distal shaft was found to be kinked/bent.A functional evaluation was not performed due to the damage 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.The reported event of 'catheter shaft leaked during use' could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that when the operator guided the subject aspiration catheter and attempted to aspirate the thrombus using the aspiration pump; it could not be aspirated at all and felt like air was leaking from the shaft near the hub.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.The catheter was returned with tegaderm dressing attached.The catheter shaft was found to be broken/fractured.The catheter distal shaft was also found to be kinked/bent.Navigation through tortuous m2 anatomy may have placed bending stress on the catheter shaft, which might have contributed to a shaft leak during aspiration.Improper flush maintenance alone would not be expected to cause a shaft breach, although high suction pressure might have increased stress on the device.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of 'catheter shaft leaked during use' as well as analyzed events of 'catheter shaft kinked/bent' and '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
It was reported that the catheter (subject device) was used in the thrombectomy procedure.However, the physician was unable to aspirate the thrombus as the subject device was felt to be leaking near shaft.The subject device was replaced, and the procedure was 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: 24425469
• Report Number: 3008853977-2026-00002
• Device Sequence Number: 17612013
• Product Code: QJP
• UDI-Device Identifier: 07613327519365
• UDI-Public: (01)07613327519365(17)271210(10)26125-01
• 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,Followup
• Report Date (Section B): 03/19/2026

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: 26125-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHIKAI GUIDEWIRE (NON STRYKER)
• Patient Sex: Unknown