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	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an aspiration thrombectomy for middle cerebral artery (mca) occlusion, physician observed that the marker band on the tip of subject catheter was detached and left behind in the patient's vasculature.The procedure was completed, and the patient was administered aspirin (asa) post-procedure.No further information is available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject catheter was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 subject catheter was not returned.Additional information provided by the customer indicated that patient was put on aspirin (asa) during additional medical intervention.The current state of the patient is unknown, and patient's anatomy was noted to be standard tortuous.The subject catheter was not returned for analysis.Therefore, the as reported codes radiopaque (ro) marker(s) detached/separated/not visible under fluoroscopy and un-retrieved device fragments cannot be confirmed.It's likely that excessive force during the subject catheter retrieval, combined with the patient's tortuous anatomy, caused the failure.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.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject catheter was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 patient was put on aspirin (asa) during additional medical intervention.The current state of the patient is unknown, and patient's anatomy was noted to be standard tortuous.The subject device was not returned for analysis.Therefore, the as reported codes radiopaque (ro) marker(s) detached/separated/not visible under fluoroscopy, un-retrieved device fragments cannot be confirmed.It's likely that excessive force during the subject catheter retrieval, combined with the patient's tortuous anatomy, caused the failure.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.
Event or Problem Description
It was reported that during an aspiration thrombectomy for middle cerebral artery (mca) occlusion, physician observed that the marker band on the tip of subject catheter was detached and left behind in the patient's vasculature.The procedure was completed, and the patient was administered aspirin (asa) post-procedure.No further 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: 20483693
• Report Number: 3008881809-2024-00486
• Device Sequence Number: 3615480
• Product Code: NRY
• UDI-Device Identifier: 07613327012033
• UDI-Public: (01)07613327012033(17)250528(10)24348551
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 11/08/2024

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: 05/28/2025
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 24348551
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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: ASPIRATION PUMP (PENUMBRA).; ASPIRATION TUBING (STRYKER).; COLOSSUS GUIDE WIRE (ARISTOTLE).; FUBUKI LONG SHEATH (ASAHI).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male