MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number	SFR3-4-40-10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The solitaire revascularization device would not feed through the marksman catheter.The device never made it into patient.There were no complications.

• Brand Name: SOLITAIRE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8657845
• Report Number: 8657845
• Device Sequence Number: 19394881
• Product Code: NRY
• UDI-Device Identifier: 00847536034006
• UDI-Public: (01)00847536034006(17)201218(10)A758824
• 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): 05/21/2019
• Report Date (Section F): 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SFR3-4-40-10
• Device Lot Number: A758824
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 05/21/2019