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

Model Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the catheter (subject device) shaft was kinked and broken near the hub.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, the catheter (subject device) shaft was kinked and broken near the hub.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the from the catheter hub.During visual inspection, the catheter was seen to be broken/fractured 3.5cm from the catheter hub.Functional inspection was not carried out due to condition of returned device.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 was seen to be broken/fractured and therefore the as reported can be confirmed.The as reported event of the catheter shaft broken/fractured during use and the catheter kinked bent as well as the as analyzed event of catheter shaft broken/fractured during use can 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 - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12076934
• Report Number: 3008881809-2021-00278
• Device Sequence Number: 3427933
• Product Code: NRY
• UDI-Device Identifier: 07613327417227
• UDI-Public: 07613327417227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183464
• 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): 09/16/2021

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 Expiration Date: 01/25/2022
• Device Model Number: IC068132
• Device Catalogue Number: IC068132
• Device Lot Number: 22081215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1