MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 115CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number IC068115A

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that during one acute thrombectomy procedure, the operator used the subject catheter to do the aspiration.The subject catheter was confirmed to be in good condition prior to use.Next, it was flushed and delivered through the guidewire to the location.When the operator attempted to perform the aspiration, the subject catheter shaft was found to be leaking and the shaft was fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS CATALYST 7 .068IN ID X 115CM - CE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19038937
• MDR Text Key: 339333541
• Report Number: 3008881809-2024-00146
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC068115A
• Device Lot Number: 23942923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNCHRO GUIDEWIRE (STRYKER).
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: Asian