MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100154H2HS-V-A2

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported that during treatment of a daca aneurysm, an embolization coil implant encountered resistance during advancement and detached within the microcatheter during retraction.The coil the was removed in its entirety along with the microcatheter.There was no reported patient injury or intervention.

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 investigation of the returned coil system found the pusher stuck inside the returned microcatheter, the implant deformed at proximal and to be attached to the pusher.The pusher was removed from the microcatheter and found the pusher stretched and broken at the middle section of the body coil.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing retraction forces over specification.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

• Brand Name: HYDROSOFT-10-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 13007930
• MDR Text Key: 285239596
• Report Number: 2032493-2021-00488
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022844
• UDI-Public: (01)00816777022844(11)181031(17)230930(10)1810311WR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K080666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 100154H2HS-V-A2
• Device Catalogue Number: 100154H2HS-V
• Device Lot Number: 1810311WR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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 Age: 67 YR
• Patient Sex: Female