MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 .058IN ID X 115CM - US; CATHETER, PERCUTANEOUS

Model Number	M003IC0581150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
Medwatch report mw5098494 received on 12-jan-2021 reported that during the procedure, the subject catheter tip broke and caused a loss of blood flow to brain arteries.The patient is reported to have prolonged hospitalization, disability, permanent damage and life threatening consequences due to this event.No other information is available.
Event or Problem Description
Medwatch report mw5098494 received on 12-jan-2021 reported that during the procedure, the subject catheter tip broke and caused a loss of blood flow to brain arteries.The patient is reported to have prolonged hospitalization, disability, permanent damage and life threatening consequences due to this event.No other information is available.
Additional Manufacturer Narrative
The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 device was not returned for analysis and therefore the as reported defects cannot be definitely confirmed.That being said, the patient vessel occlusion can be confirmed based on the detailed event description and can be assigned procedural factors this complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as reported catheter tip broken/fractured during use will not be confirmed, as this cannot be confirmed as the device was not returned.This will be assigned undeterminable.

• Brand Name: AXS CATALYST 5 .058IN ID X 115CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11293457
• Report Number: 3008881809-2021-00070
• Device Sequence Number: 4997265
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: 07613327012019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151667
• 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): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: M003IC0581150
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 22312232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Disability