MAUDE Adverse Event Report: STRYKER CORPORATION TARGET XL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M0036129300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker neuro coil deployed in catheter.

• Brand Name: TARGET XL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 18516959
• Report Number: 18516959
• Device Sequence Number: 17837561
• Product Code: KRD
• UDI-Device Identifier: 04546540711618
• UDI-Public: (01)04546540711618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/29/2023
• Report Date (Section F): 12/29/2023

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: M0036129300
• Device Catalogue Number: 612930
• Device Lot Number: 23947861
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2024
• 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 Sex: Male
• Patient Weight: 70 KG
• Date Report Sent to FDA: 12/29/2023