MAUDE Adverse Event Report: MICROVENTION INC. AZUR SOFT3D DETACHABLE 10; VASCULAR EMBOLIZATION DEVICE

Model Number MV-HS00410

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that during an emergency bleeding case, a coil was advanced through the microcatheter and into the intended location.During detachment using the v-grip, the light did not turn green.The coil was then pulled back and prematurely detached inside the microcatheter.Saline was flushed into the microcatheter, but the saline did not flow out from the tip of the microcatheter.The entire coil and microcatheter were both removed from the patient.The final angiography confirmed that the blood flow stopped as planned in the coiling procedure before the defect occurred.No reported patient injury or intervention.The patient's condition was reported as no health damage.

Manufacturer Narrative

This device is not marketed or sold in the us; however, is deemed similar to a v-trak hydrosoft 3d which is u.S.Approved.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Batch review: 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.Complaint system review: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Ifu review (additional information can be found in the ifu): please refer to the japanese ifu for precautions, warnings, and further information.The following is taken from the english version: 5.Introduction and deployment of the coil delivery system 5-3 seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the rhv lightly around the introducer sheath to secure the rhv to the introducer sheath.Caution·do not over-tighten the rhv around the introducer sheath.[excessive tightening could damage the pusher catheter such as kinking.] 5-4 push the coil into the lumen of the microcatheter.Caution·avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter.·initiate timing using a stopwatch or timer at the moment the coil enters the microcatheter.5-5 push the pusher catheter through the microcatheter until the proximal end of the pusher catheter meets the proximal end of the introducer sheath.Loosen the rhv.Retract the introducer sheath just out of the rhv.Close the rhv around the pusher catheter.Caution·avoid kinking the pusher catheter and introducer sheath.·to prevent premature hydration of the azur system, ensure that there is flow from the saline flush 5-7 under fluoroscopic guidance, slowly advance the coil into the vessel/aneurysm from the tip of the microcatheter.5-8 continue to advance the coil into the lesion until optimal deployment is achieved.Reposition if necessary.Caution·if the coil size is not suitable, remove and replace with another more appropriately sized coil.·do not rotate the pusher catheter during or after deployment of the coil into the vessel/aneurysm.[rotating the pusher catheter may result in a stretched coil or premature detachment of the coil from the pusher catheter, which could result in coil migration.].

• Brand Name: AZUR SOFT3D DETACHABLE 10
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• 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: 18049203
• MDR Text Key: 327299514
• Report Number: 2032493-2023-01021
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892128370
• UDI-Public: (01)04987892128370(11)230320(17)280229(10)0000339184
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-HS00410
• Device Lot Number: 0000339184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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