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

Model Number 45-480420-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 10/28/2020

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 returned to the manufacturer for evaluation.The investigation is currently underway.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 a peripheral coil embolization procedure, the embolization coil would not advance and then detached during the removal attempt.The coil was removed in its entirety together with the catheter.There was no reported patient injury or additional intervention.

Manufacturer Narrative

The investigation of the returned device confirmed the implant coil was detached from the pusher and stuck inside the microcatheter, as reported.The exact conditions or circumstances that led to the detachment could not be determined; however, the findings are consistent with damage that occurs from the application of excessive forces to the monofilament.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10906628
• MDR Text Key: 222123153
• Report Number: 2032493-2020-00350
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)191204(17)241130(10)1912045JB
• Combination Product (y/n): N
• PMA/PMN Number: K090168
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 45-480420-L
• Device Catalogue Number: 45-480420
• Device Lot Number: 1912045JB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1