MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; PERIPHERAL

Model Number 45-480204-L

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that a patient was being treated for a hematoma bleed with a glidecatheter and a micro catheter.Once the bleed was canulated the first coil was placed and detached successfully.A second coil was placed and attempted to be detached multiple times unsuccessfully with a detachment controller.The physician decided to withdrawal the coil and unintentionally detached in the micro catheter.The coil was removed with the catheter in its entirety.There was no reported patient injury or intervention.

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 was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The complaint as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies difficult or premature coil detachment as a potential complication associated with the use of the device.

Manufacturer Narrative

Investigation conclusion the investigation of the returned coil system found the pusher returned without the implant attached, and the pusher hypotube kinked at the proximal section.The implant was returned separated from the pusher with the overcoil stretched and was stuck within the middle section of the microcatheter.The unit did not pass continuity and resistance testing.Further inspection of the pusher found the green lead wire broken and the clear pet damaged at the proximal solder joint, which is consistent with non-detachment.The pusher's monofilament showed a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.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.The microcatheter used in the procedure was found damaged at multiple areas, which may have caused or contributed to the separation of the coil from the pusher.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18723146
• MDR Text Key: 336622974
• Report Number: 2032493-2024-00139
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-480204-L
• Device Lot Number: 2001155KB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2020
• 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