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

Model Number	M0035421530
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The target coils would not go through the catheter.

• Brand Name: TARGET
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8594878
• Report Number: 8594878
• Device Sequence Number: 2010901
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: (01)04546540697943
• 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): 05/03/2019
• Report Date (Section F): 05/03/2019

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: M0035421530
• Device Catalogue Number: 542153
• Device Lot Number: 20485740
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 44
• Date Report Sent to FDA: 05/03/2019