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

Model Number	M0035422060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure for coil embolization, the target coil would not advance into the microcatheter.It did not enter the patient, and there was no patient harm.Manufacturer response for device, neurovascular embolization, target (per site reporter).Sent shipper kit to return the device to the manufacturer.

• Brand Name: TARGET
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 2825 airview blvd; portage MI 49002
• MDR Report Key: 9626821
• Report Number: 9626821
• Device Sequence Number: 11459195
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: (01)07613252239345(17)220525(10)21449080
• 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): 01/22/2020
• Report Date (Section F): 01/23/2020

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: M0035422060
• Device Catalogue Number: 542206
• Device Lot Number: 21449080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 47
• Date Report Sent to FDA: 01/23/2020