MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICALVTA; ARTIFICIAL EMBOLIZATION DEVICE

Model Number 100204HS-V-A2

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/27/2021

Event Type  malfunction  

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 returned to the manufacturer for evaluation.The investigation is currently underway.

Event Description

It was reported that the coil exit marker located on the pusher outside of the patient was not in the correct location.There was no reported patient injury.

Manufacturer Narrative

The reported complaint is confirmed; the investigation of the returned coil system found two platinum coils attached to the pusher's body coil.The warning mark was measured at 148cm from the distal end of the implant and is confirmed to be in the correct location per the manufacturing procedure.The manufacturing process for this device has multiple inspections performed in process and by quality to confirm the correct location of the warning mark and marker coils of the pusher.The findings from this investigation have been communicated to quality.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11579925
• MDR Text Key: 243409465
• Report Number: 2032493-2021-00099
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777020604
• UDI-Public: (01)00816777020604(11)200901(17)250831(10)2009015PH
• Combination Product (y/n): N
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100204HS-V-A2
• Device Lot Number: 2009015PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1