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

Model Number	M003DC050150A0
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Stroke/CVA (1770); Foreign Body In Patient (2687)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the ro marker of catheter (subject device) dislodged from catheter and became stuck in mca branch.The physician attempted to remove the ro marker from the patient's anatomy but was not able to remove from vessel.The detached ro marker of subject catheter remains inside the patient's anatomy.Surgical delay of 3 hours was reported and the procedure was not completed successfully.It was reported that the patient was experiencing stroke like symptoms and is under added medication.No other clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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 ro marker detached/separated/not visible under fluoroscopy and un-retrieved device fragments cannot be confirmed and therefore undeterminable will be assigned to these as reported codes.The as reported patient stroke is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that the ro marker of catheter (subject device) dislodged from catheter and became stuck in mca branch.The physician attempted to remove the ro marker from the patient's anatomy but was not able to remove from vessel.The detached ro marker of subject catheter remains inside the patient's anatomy.Surgical delay of 3 hours was reported and the procedure was not completed successfully.It was reported that the patient was experiencing stroke like symptoms and is under added medication.No other clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the ro marker of catheter (subject device) dislodged from catheter and became stuck in mca branch.The physician attempted to remove the ro marker from the patient's anatomy but was not able to remove from vessel.The detached ro marker of subject catheter remains inside the patient's anatomy.Surgical delay of 3 hours was reported and the procedure was not completed successfully.It was reported that the patient was experiencing stroke like symptoms and is under added medication.No other clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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 events cannot be confirmed and therefore undeterminable will be assigned to these as reported codes.

• 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: 10970208
• Report Number: 3008881809-2020-00382
• Device Sequence Number: 2470176
• Product Code: DQY
• UDI-Device Identifier: 07613327361155
• UDI-Public: 07613327361155
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/01/2021

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: M003DC050150A0
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 22312230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/22/2021; 02/05/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/28/2021; 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT-17 (STRYKER); INFINITY PLUS CATHETER (STRYKER); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention