MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number MV-00308HHTA

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/19/2020

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 was implanted in the patient and the delivery pusher was not returned to the manufacturer for evaluation; therefore, the reported event cannot be confirmed.

Event Description

It was reported that the coil exit marker was not seen on the delivery pusher.The coil was successfully implanted without incident.There was no reported patient injury.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10865342
• MDR Text Key: 217146456
• Report Number: 2032493-2020-00333
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350006714
• UDI-Public: (01)04987350006714(11)200115(17)241231(10)2001155X6
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-00308HHTA
• Device Lot Number: 2001155X6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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