MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 125CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number IC068125A

Device Problem Fracture (1260)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported during a accute thrombectomy procedure while the subject catheter was being delivered to the treatment site, the physician felt loss of support and could not manipulate the device.It was removed and the subject catheter was found fractured in the middle of the outer shaft.The physician replaced the device and the procedure was completed successfully with no clinical consequences to the patient.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection the catheter shaft was seen to be broken exposing the inner coil wind 65cm from the catheter hub.Functional testing was not required as the defect was confirmed during device analysis.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 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.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.During the analysis the catheter shaft was seen to be broken exposing the inner coil wind.No other visuals defects were found during device analysis.An assignable cause of procedural factors will be assigned to reported and analyzed event of the 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 Description

It was reported duing a accute thrombectomy procedure while the subject catheter was was being delivered to the treatment site, the physician felt loss of support and could not manipulate the device.It was removed and the subject catheter was found fractured in the middle of the outer shaft.The physician replaced the device and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: AXS CATALYST 7 .068IN ID X 125CM - 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: 16297653
• MDR Text Key: 309140184
• Report Number: 3008881809-2023-00056
• 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,Followup
• Report Date: 03/29/2023

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: IC068125A
• Device Lot Number: 23771683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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: CODIS 8F GUIDE CATHETER; SYNCHRO GUIDEWIRE (STRYKER); TREVO PRO 18 RETRIEVER (STRYKER)
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: Asian