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

Model Number 45-751019

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with this 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 not yet been returned to the manufacturer; therefore, a product evaluation could not be performed and the alleged product issue could not be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.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 treatment of a fistula, an embolization coil implant detaced prematurely within the catheter.The coil was removed and another was used.There was no reported intervention or patient injury.

Manufacturer Narrative

The implant was returned along with the snare, which was stuck in the microcatheter.The coil pusher was not returned.Without the return and evaluation of the pusher, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).No notable conditions were found on the returned microcatheter.The implant was returned damaged, which is consistent with using a snare device to retrieve it as indicated in the complaint.Since the investigation could not verify the mode of implant separation due to the absence of the pusher, the reported event is considered non-verifiable.

• Brand Name: AZUR CX 35 DETACHABLE
• Type of Device: VASCULAR 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: 13058220
• MDR Text Key: 282612975
• Report Number: 2032493-2021-00505
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)210528(17)260430(10)2105285J2
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 2105285J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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