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

Model Number MV-HS00103

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

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Items returned: the device was discarded by the user facility.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.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.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.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: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.

Event Description

It was reported that after flushing an implant coil in it¿s packaging hoop and immersing the holder in a tray filled with saline solution, ink on the barcode label attached to the holder began to flake off.The tray was full of black ¿foreign materials¿ scattered in the saline solution.Therefore, the coil was not used and the coil and tray were replaced with new ones.Subsequently, the procedure was completed successfully.There was no patient involvement.

Event Description

Ink on barcode label came off: after flushing the coil in the holder and immersing the holder in a tray filled with saline solution, ink on the barcode label attached to the holder began to flake off.The tray was full of black foreign materials scattered in the saline solution.Therefore, use of the coil was aborted, and the coil and tray were replaced with new ones.Subsequently, the procedure was completed successfully.

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.

• Brand Name: AZUR SOFT3D DETACHABLE 10
• Type of Device: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92868
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17145112
• MDR Text Key: 317759910
• Report Number: 2032493-2023-00799
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892128189
• UDI-Public: (01)04987892128189(11)220905(17)270831(10)0000256359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071939
• 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,Followup
• Report Date: 06/05/2023

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-HS00103
• Device Lot Number: 0000256359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1