MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; VASCULAR EMBOLIZATION DEVICE

Model Number 45-780204-L

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 implanted in the patient and not available to the manufacturer for analysis.Therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that the embolization coil implant was passed through a microcatheter catheter fine and tracked into position and was detached per usual technique.However, when removing the pusher wire, a portion of the coil tracked back into the microcatheter.Reportedly, the physician was able to place the coil in position in the patient.There was no repo of harm or injury to the patient, who was stable.

Manufacturer Narrative

The implant was not returned for analysis and was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The pusher was the only component returned for evaluation.The investigation of the returned pusher found the pusher with burn marks on the heater coil, indicating the device was activated using a detachment controller.The monofilament was removed from the pusher's body coil and profiles a mushroom shape tip, which is consistent with a successful detachment.The device was tested with a compatible lab provided v-grip controller and passed the 4-way continuity test.The pusher resistance measured "38.5ohm" (38-52ohm = specification) and the proximal connector measured "ol" (ol = specification).The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: AZUR CX 18D-LONGER
• 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: 12807875
• MDR Text Key: 284613358
• Report Number: 2032493-2021-00442
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00816777024374
• UDI-Public: (01)00816777024374(11)200302(17)250228(10)2003025Z8
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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: Health Professional
• Device Model Number: 45-780204-L
• Device Lot Number: 2003025Z8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• 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 Sex: Female