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.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the catheter shaft was seen to be broken/fractured 13.5 cm from the catheter shaft.The catheter shaft was seen to be kinked/bent 44 and 68 cm from the catheter shaft.The catheter tip and the hub were intact.Functional inspection was not carried out 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 ¿catheter shaft broken/fractured during use¿ was confirmed during analysis.The reported event ¿catheter shaft leak during use¿ could not be duplicated 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.Additional information provided by the customer indicated that 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.Continuous flush was set up and maintained throughout the clinical procedure.Patient's anatomy was moderately tortuous.It was reported, 'during one acute thrombectomy case, the operator used catheter to do aspiration.Checked before use and no anomaly was noticed.Flushed and delivered it through guidewire and after reaching the location, the operator use it to do aspiration but he found it leaked.Checked the catheter and found the area closed to hub was fractured.Replaced it with another catheter from other brand to finish the procedure'.During analysis the catheter shaft was seen to be broken/fractured 13.5 cm from the catheter shaft.The catheter shaft was seen to be kinked/bent 44 and 68 cm from the catheter shaft.The catheter tip and the hub were intact.An assignable cause of procedural factors will be assigned to the reported events: catheter shaft broken/fractured during use, catheter shaft leak during use as well as the analyzed events: catheter shaft kinked/bent, catheter shaft broken/fractured during use as this issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

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

• 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
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/03/2024
• 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