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

Model Number 100154HS3D-V

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/15/2020

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

Event Description

It was reported that the proximal coil exit marker was missing from the delivery pusher.There was no reported patient injury.

Manufacturer Narrative

Visual inspection of the pusher confirmed that the exit markers on the proximal portion of the pusher were not applied.These exit markers are applied on the proximal portion of the pusher, which remain outside the patient during the procedure.There have been no other complaints reported for this issue for other devices from the same lot.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 10878115
• MDR Text Key: 217683653
• Report Number: 2032493-2020-00339
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021014
• UDI-Public: (01)00816777021014(11)200422(17)250331(10)2004225WT
• Combination Product (y/n): N
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100154HS3D-V
• Device Lot Number: 2004225WT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65