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

Model Number	M0035443560
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The target coil didn't deploy out of the casing; it did not push out of the sheath.It did not come in contact with the patient.Manufacturer response for device, neurovascular embolization, target (per site reporter).They sent a (b)(6) label to return the device to the manufacturer.

• Brand Name: TARGET
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10894160
• Report Number: 10894160
• Device Sequence Number: 3285493
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: (01)07613252600343(17)230715(10)22330936
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/18/2020
• Report Date (Section F): 11/18/2020

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: M0035443560
• Device Catalogue Number: 544356
• Device Lot Number: 22330936
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 11/18/2020