MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; PERIPHERAL

Model Number 45-480202-L

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 03/20/2023

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 analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention will issue a supplemental report.The instructions for use (ifu) identifies delayed or premature coil detachment as potential complications associated with use of the device.

Event Description

It was reported that during an embolization treatment for a gi bleed, the embolization coil would not detach with multiple attempts or detachment controllers.It was decided to withdraw the device with approximately one quarter of the coil into the catheter, the coil prematurely detached from the delivery pusher.The catheter was flushed with saline and contrast to flush the coil to deploy at the treatment site.The case was completed.The patient is reported sable and doing well.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrance callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16651990
• MDR Text Key: 312462090
• Report Number: 2032493-2023-00641
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00810170017841
• UDI-Public: (01)00810170017841(11)211116(17)261031(10)0000123575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-480202-L
• Device Catalogue Number: 45-480202
• Device Lot Number: 0000123575
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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 Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male