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

Model Number MV-00728HHTA

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/21/2022

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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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reported that when the microcatheter was advanced, the microcatheter moved back proximally.The coil was attempted to be withdrawn from the microcatheter, but the coil stretched and broke.After cutting the microcatheter, the coil was retracted with a snare and removed from the patient.Another coil was used to continue the procedure, and the procedure was successfully completed.There was no harm to the patient reported.

Event Description

Please see h10 for investigation conclusion.

Manufacturer Narrative

The investigation of the returned coil system found the implant coils severely stretched, tangled on the snare device, and separated from the pusher.The pusher coils were returned stretched and stuck inside the microcatheter.Further inspection found the implant's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The microcatheter used in the procedure was found kinked at the distal section, which may have caused or contributed to the reported complaint.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 forces over specification.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15973229
• MDR Text Key: 305412571
• Report Number: 2032493-2022-00547
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987892070396
• UDI-Public: (01)04987892070396(11)220607(17)270531(10)0000205289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MV-00728HHTA
• Device Lot Number: 0000205289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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