MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR 1018 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031441900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Movement Disorder (4412); Speech Disorder (4415); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that within 48 hours after procedure, the patient experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.
Additional Manufacturer Narrative
This is 3 of 3 mdr reports.
Event or Problem Description
It was reported that within 48 hours after procedure, the patient experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.Updated: received additional information stated that the adverse event has been updated to ischemic stroke.
Additional Manufacturer Narrative
Section b executive summary: updated.F10 clinical signs code grid: added ¿ischemia stroke¿ due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.Additional information provided by the customer indicated that multiple microembolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand" which was updated to "ischemic stroke, possibly related to the subject microcatheter.While there are a number of potential causes for the reported issues, because the product was not returned, review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

• Brand Name: EXCELSIOR 1018 PRE-SHAPED 45 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22074544
• Report Number: 3008881809-2025-00295
• Device Sequence Number: 15787229
• Product Code: DQY
• UDI-Device Identifier: 04546540688132
• UDI-Public: (01)04546540688132(17)250908(10)24494214
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042568
• 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): 08/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2025
• Device Catalogue Number: M0031441900
• Device Lot Number: 24494214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 70 KG