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

Model Number 45-750824

Device Problem Fracture (1260)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

It was reported that during a coil embolization procedure, the coil was repositioned and it was observed that the delivery pusher broke within the catheter.No secondary intervention was reported, no patient harm was incurred.

Manufacturer Narrative

A search for non-conformance's 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 been returned to the manufacturer as of date of this report; therefore, the report issue could not confirmed at this time.If the device or additional information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Manufacturer Narrative

Additional information: h10 (summary device evaluation).Summary device evaluation: the implant was the only component received for evaluation.The investigation of the returned implant found the proximal end severely stretched and broken with the marker band missing.Due to the missing pusher, the investigation is unable to determine the cause of the reported complaint; therefore, this 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: 13806144
• MDR Text Key: 288697234
• Report Number: 2032493-2022-00090
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00812636021065
• UDI-Public: (01)00812636021065(11)210616(17)260531(10)2106165K2
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-750824
• Device Catalogue Number: 45-750824
• Device Lot Number: 2106165K2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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