MAUDE Adverse Event Report: STRYKER CORPORATION TARGET TETRA; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	TG5414510
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: using coils during embolization for neuro coil unable to be pushed through microcath.Coil was 4.5x10 target tetra coil.

• Brand Name: TARGET TETRA
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazo MI 49001
• MDR Report Key: 22929653
• Report Number: 22929653
• Device Sequence Number: 18699779
• Product Code: HCG
• UDI-Device Identifier: 07613327578744
• UDI-Public: (01)07613327578744
• 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): 08/22/2025
• Report Date (Section F): 08/22/2025

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: TG5414510
• Device Catalogue Number: TG5414510
• Device Lot Number: 24335471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Date Report Sent to FDA: 08/22/2025