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

Model Number	M0035421520
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Provider met resistance and was not able to advance and deploy the coil.

• Brand Name: TARGET
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 18442761
• Report Number: 18442761
• Device Sequence Number: 17849039
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: (01)04546540697981(17)240810(10)230161677
• 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): 12/18/2023
• Report Date (Section F): 12/18/2023

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: M0035421520
• Device Catalogue Number: 542152
• Device Lot Number: 230161677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• 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: Female
• Patient Weight: 83 KG
• Patient Race: White
• Date Report Sent to FDA: 12/18/2023