MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; Catheter, Percutaneous

Catalog Number	UNK_NEU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 1 day post procedure for an intracranial aneurysm, the patient developed right groin pseudoaneurysm.It was treated with ultrasound guided thrombin injection.The event was causally related to procedure and probably related to subject long sheath that was used during the procedure.The event was considered as a serious adverse event.No further information is available.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• 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 ; +1(510)413-2500
• MDR Report Key: 25280446
• Report Number: 3008881809-2026-00337
• Device Sequence Number: 10059647
• Product Code: DQY
• UDI-Device Identifier: 07613327298260
• UDI-Public: (01)07613327298260(17)290104(10)26061122
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152876
• 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): 08/06/2026

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 Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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: SURPASS ELITE WITH GUARDIAN FD (STRYKER).; XT27 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female