MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX PERIPHERAL COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-781434
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to thread into catheter after multiple attempts by competent rad techs and physicians in a very critical, bleeding pt.Attempted with two catheters of this size.Six different coils attempted with malfunction.Another product used to stabilized the pt.Two coils successfully used.

• Brand Name: AZUR CX PERIPHERAL COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.
• MDR Report Key: 9219304
• Report Number: MW5090533
• Device Sequence Number: 16242718
• Product Code: KRD
• UDI-Device Identifier: 00810170018374
• UDI-Public: 00810170018374
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/01/2019
• 4 Devices were Involved in the Event: 1 2 3 4

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 Expiration Date: 11/30/2021
• Device Model Number: 45-781434
• Device Catalogue Number: 45-781434
• Device Lot Number: 161214LC8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2019
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 68