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

Model Number MV-00612HHTA

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil remains in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis was not performed.The root cause cannot be determined.

Event Description

It was reported that the coil did not form properly in the aneurysm and then stretched after repeated attempts were made to push and pull the coil.During removal, the coil detached in the vessel.The detached coil was left in position in the vessel and the procedure was terminated.No bloodflow anomalies were noted on the final angiogram.There was no reported patient injury or health damage.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7343156
• MDR Text Key: 102724982
• Report Number: 2032493-2018-00048
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987892070310
• UDI-Public: (01)04987892070310(11)171002(17)220930(10)17100256A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080666
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Model Number: MV-00612HHTA
• Device Lot Number: 17100256A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2017
• 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