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

Model Number	100204HS-V-A2
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11579925
• Report Number: 2032493-2021-00099
• Device Sequence Number: 3621734
• Product Code: HCG
• UDI-Device Identifier: 00816777020604
• UDI-Public: (01)00816777020604(11)200901(17)250831(10)2009015PH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• 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
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1