MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 45-480815-L

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during embolization of a splenic artery embolization, the physician encountered resistance during advancement.Upon retraction, the coil had detached.The coil was removed without intervention.There was no reported patient injury.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12207978
• MDR Text Key: 262901979
• Report Number: 2032493-2021-00280
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017971
• UDI-Public: (01)00810170017971(11)200204(17)250131(10)2002045KB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-480815-L
• Device Catalogue Number: 45-480815
• Device Lot Number: 2002045KB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 61