MAUDE Adverse Event Report: EV3 NEUROVASCULAR SOLITAIRE 2

Catalog Number SAFR2-4-40

Device Problem Difficult to Insert (1316)

Patient Problem No Patient Involvement (2645)

Event Date 03/31/2016

Event Type  malfunction  

Event Description

When trying to insert the solitaire 2 revascularization device, the device would not pass through the sheath.The device never entered the pt.Device will be given to rep for solitaire, (b)(6).

• Brand Name: SOLITAIRE 2
• Type of Device: SOLITAIRE 2
• Manufacturer (Section D): EV3 NEUROVASCULAR; irvine CA 92618
• MDR Report Key: 5551799
• MDR Text Key: 42067756
• Report Number: MW5061491
• Device Sequence Number: 1
• Product Code: NRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: SAFR2-4-40
• Device Lot Number: A116288
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 89