MAUDE Adverse Event Report: MICROVENTION, INC. AZUR SOFT3D DETACHABLE 10; PERIPHERAL

Model Number MV-HS00310

Device Problems Use of Device Problem (1670); Device Markings/Labelling Problem (2911)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported that while the dispenser hoop and azur coil system were immersed in a container of saline solution prior to use, the ink on the barcode label attached to the dispenser hoop peeled off in flakes into the saline container.The coil was successfully implanted.No patient harm or injury was reported.

Manufacturer Narrative

A search for non-conformances 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 stated to be available for return to the manufacturer for evaluation, but has not yet been returned for analysis; therefore, the alleged product issue cannot be confirmed at this time.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 premature coil detachment as potential complications associated with use of the device.

Manufacturer Narrative

Upon further review of the details provided in the reported event, it was determined that the issue described is the result of a user-performed device preparation process that deviated from the ifu.As such, the medical device problem code is being changed from 2911 to 1670.

Manufacturer Narrative

Items returned for evaluation: -dispenser hoop (3) items not returned for evaluation: pusher.Implant.Introducer.Shrink lock.Microcatheter.V-grip.The visual analysis of the returned items found the barcode label print peeled off in flakes.The english translation of the instructions provided in azur soft 3d ifu, indicates that, as a pre-preparation step, the azur soft 3d should be flushed with heparinized saline as described below: 1) remove the azur soft 3d together with the dispenser hoop from the pouch.2) use a syringe to flush the dispenser hoop from the dispenser hub with a minimum of 3ml of heparinized saline so that the distal surface of the azur soft 3d becomes adequately wet.3) gently remove the proximal end of the azur soft 3d from the dispenser hoop.

• Brand Name: AZUR SOFT3D DETACHABLE 10
• 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: 16705157
• MDR Text Key: 312981931
• Report Number: 2032493-2023-00656
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892128349
• UDI-Public: (01)04987892128349(11)220929(17)270831(10)0000266435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2023

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: MV-HS00310
• Device Lot Number: 0000266435
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/08/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 07/07/2023
• Supplement Dates FDA Received: 06/27/2023; 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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
• Patient Outcome(s): Other