MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; VASCULAR EMBOLIZATION DEVICE

Model Number 100520H2HS-V-A2

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

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.The device was implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that upon removing the delivery pusher from the dispenser hoop, the delivery pusher was observed to be bent.The device passed the pre-test.During positioning, the implant coil detached from the delivery pusher.The coil was removed successfully using an endovascular snare.The patient was reported to be "good." there was no reported patient injury or sequela.

• Brand Name: HYDROSOFT HELICAL
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11579782
• MDR Text Key: 242677000
• Report Number: 2032493-2021-00096
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023018
• UDI-Public: (01)00816777023018(11)200518(17)250430(10)2005185WR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K070656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2021

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100520H2HS-V-A2
• Device Catalogue Number: 100520H2HS-V
• Device Lot Number: 2005185WR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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): Required Intervention