MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACHABLE HYDRO; VASCULAR EMBOLIZATION DEVICE

Model Number 45-452030

Device Problems Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)

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

Event Date 01/12/2021

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 has been returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment and difficult or delayed coil detachment as potential complications associated with use of the device.

Event Description

It was reported that during a peripheral coil embolization procedure, the embolization coil did not detach and during removal, the embolization coil detached in the catheter.The coil was removed from the patient without incident.There was no reported patient injury or additional intervention.

Manufacturer Narrative

The reported complaint is confirmed.The investigation of the returned coil system found that the implant did experience a tensile break based on the shape and profile of the monofilament.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11325948
• MDR Text Key: 232218765
• Report Number: 2032493-2021-00047
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00810170015045
• UDI-Public: (01)00810170015045(11)191112(17)241031(10)1911125JG
• Combination Product (y/n): N
• PMA/PMN Number: K093002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-452030
• Device Catalogue Number: 45-452030
• Device Lot Number: 1911125JG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1