MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number	M003IC0601320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the aspiration procedure in the distal internal carotid artery (ica) the marker band of the subject catheter got detached inside the patient.Another non-stryker aspiration catheter was used to attempt to collect the tip but was unsuccessful.The marker tip migrated to the external carotid artery (eca) branch all the way to the ear.The current condition of the patient is not well, but the physician states no cause to the detached marker.No other information is available.
Additional Manufacturer Narrative
D4 gtin ¿ corrected.G4 510(k) - corrected.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.It was reported, 'catalyst 6 was used for aspiration at distal internal carotid artery (ica).After aspiration using penumbra pump he collected the catheter and the tip of the catalyst 6 marker band tip got detached inside the patient.Sofia was used to collect the tip but it migrated to external carotid artery (eca) branch all the way to the ear.Another devices were used to finish the case'.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the patient's condition is not so good.However, the initial reporter mentioned that the cause of the patient's condition is not the catalyst marker but the lesion on the surgery site is not fully recovered.The blood flow of the vessel which the marker remained is normal.Although, there is no clear information regarding the patient's anatomy, it is likely that excessive force applied to remove the catheter combined with the tortuous anatomy of the patient cause the reported failure.The device was not returned for analysis.Therefore, the as reported cannot be confirmed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported catheter tip broken/fractured during use and un-retrieved device fragments.
Event or Problem Description
It was reported that following the aspiration procedure in the distal internal carotid artery (ica) the marker band of the subject catheter got detached inside the patient.Another non-stryker aspiration catheter was used to attempt to collect the tip but was unsuccessful.The marker tip migrated to the external carotid artery (eca) branch all the way to the ear.The current condition of the patient is not well, but the physician states no cause to the detached marker.No other information is available.

• Brand Name: AXS CATALYST 6 .060IN 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
• 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: 20098580
• Report Number: 3008881809-2024-00384
• Device Sequence Number: 7794565
• Product Code: NRY
• UDI-Device Identifier: 07613327012033
• UDI-Public: (01)07613327012033(17)251002(10)24558096
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173841
• 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): 11/01/2024

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: 10/02/2025
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 24558096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOFIA MICROCATHETER (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown