MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number IC068132A

Device Problem Fracture (1260)

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

Event Date 03/18/2023

Event Type  malfunction  

Event Description

It was reported that during the thrombectomy procedure, the subject catheter shaft was broken/fractured.The physician was unable to perform the thromboaspiration due to the presence of air bubbles.The physician replaced it with a new device and completed the procedure successfully.Additional information received on 24-mar-2023 confirmed that the patient died due to the underlying aortic value disease.Additional information received on 11-apr-2023 clarified that the subject catheter breakage did not contribute to the patient's death and the cause of death of the patient was probably multifactorial, including aortic valve disease.The patient was in fluid overload of cardiogenic origin before the procedure.

Event Description

It was reported that during the thrombectomy procedure, the subject catheter shaft was broken/fractured.The physician was unable to perform the thromboaspiration due to the presence of air bubbles.The physician replaced it with a new device and completed the procedure successfully.Additional information received on 24-mar-2023 confirmed that the patient died due to the underlying aortic value disease.Additional information received on 11-apr-2023 clarified that the subject catheter breakage did not contribute to the patient's death and the cause of death of the patient was probably multifactorial, including aortic valve disease.The patient was in fluid overload of cardiogenic origin before the procedure.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the catheter shaft was seen to be broken/fractured 6.5cm from the catheter hub.The catheter shaft was seen to be kinked/bent 93cm and 115.5cm from the catheter hub.Functional inspection was not required as the defect was confirmed during device analysis.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The catheter shaft was seen to be broken/fractured and kinked/bent, therefore conforming the as reported event.The as reported as well as the as analyzed code, ¿catheter shaft broken/fractured during use' as well as the analyzed code, 'catheter shaft kinked/bent' will be assigned procedural factors 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.

• Brand Name: AXS CATALYST 7 .068IN ID X 132CM - 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: 16737397
• MDR Text Key: 313672264
• Report Number: 3008881809-2023-00185
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/24/2023

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 Catalogue Number: IC068132A
• Device Lot Number: 23897376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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: NEURON MAX LONG SHEATH (PENUMBRA)