MAUDE Adverse Event Report: STRYKER NEUROVASCULAR INZONE; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M00345100950
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: s [situation]: mma [middle meningeal artery] embolization being completed.A stryker coil detacher was opened lot # wmp137646 was opened and the pull tab was not there, and the device would not turn on.B [background]: a stryker coil needed to be used to complete the procedure to prevent further growth of sdh [subdural hematoma].A [assessment]: a device malfunction.A second device was opened and was successful.R [recommendation]: rep may want to be notified to let them know there was a malfunction in product.A second coil detacher was opened and did work.

• Brand Name: INZONE
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 24290915
• Report Number: 24290915
• Device Sequence Number: 13113615
• Product Code: HCG
• UDI-Device Identifier: 04546540697950
• UDI-Public: (01)04546540697950
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026
• Report Date (Section F): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00345100950
• Device Catalogue Number: 451009-5
• Device Lot Number: WMP137646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 02/04/2026