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

Model Number 100152HS-V-A2

Device Problems Device Markings/Labelling Problem (2911); Appropriate Term/Code Not Available (3191)

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

Event Date 12/15/2020

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 has not yet been returned to the manufacturer for evaluation.

Event Description

It was reported that the coil exit marker located on the pusher outside the patient was not visible.The device was removed from the patient.There was no reported patient injury.

Manufacturer Narrative

The investigation of the returned coil system found the pusher with no warning mark on the hypotube.H6 - medical device problem code - the correct code is 2911.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11182396
• MDR Text Key: 227753144
• Report Number: 2032493-2021-00014
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777020543
• UDI-Public: (01)00816777020543(11)200625(17)250531(10)2006255PH
• Combination Product (y/n): N
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 100152HS-V-A2
• Device Lot Number: 2006255PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR