MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA 5F 115 CM STR; GUIDE CATHETER

Model Number	DA5115ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/18/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the information provided.The root cause of this complaint cannot be determined.No portion of the device was reported available.(b)(4).
Event or Problem Description
It was reported that the patient presented with severe stoke on (b)(6) 2016.A thrombectomy was performed in the interventional suite.Mechanical thrombectomy was performed using the following devices: 6fr shuttle sheath, 5fr 115cm sofia catheter, solitare stentreiver, marksman.027.The patient was reported to incur a stroke, multiple brain infarcts, clot resulting in death.A foreign body material, unidentified substance also was observed in the pathology report on (b)(6) 2016.The pathologist is further investigating the foreign body material substance.No specific device malfunction was reported.This incident is being reported as a death occurred.Two sofia devices were reported, however one device was opened and was accidentally dropped on the floor.The reporter could not determine what device was used or which one was dropped on the floor.The second device lot reported is: 151223jc4 (mvi ref.: p16-3246).

• Brand Name: SOFIA 5F 115 CM STR
• Common Device Name: GUIDE CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5934725
• Report Number: 2032493-2016-00211
• Device Sequence Number: 19036224
• Product Code: DQY
• UDI-Device Identifier: 00812636020082
• UDI-Public: (01)00812636020082(11)151030(17)181030(10)151030TC1
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/30/2018
• Device Model Number: DA5115ST
• Device Lot Number: 151030TC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR