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

Model Number MV-00304HHTA

Device Problem Component Missing (2306)

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

Event Date 05/09/2023

Event Type  malfunction  

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.

Event Description

It was reported that during coil embolization of a cerebral aneurysm, the seventh coil was inserted into a microcatheter after checking the electrical continuity.When the coil was being inserted under fluoroscopic guidance, only the radiopaque marker was visible; the implant was found to be invisible.The coil system was therefore withdrawn; however, no implant was found in the microcatheter or surrounding area.The coil was replaced with another coil, and the procedure was successfully completed.There was no patient harm reported.

Manufacturer Narrative

The investigation of the returned coil system found the implant separated from the pusher without any signs of activation observed on the pusher heater coil; however, a mushroom profile was observed on the pusher's monofilament indicating thermal detachment of the implant using a detachment controller did occur.Although it was stated that the implant was missing, this investigation could not determine whether the implant went missing before the package was opened or during the procedure.As a result, this complaint is considered non-verifiable.

• 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: 17035547
• MDR Text Key: 316416998
• Report Number: 2032493-2023-00756
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987892028977
• UDI-Public: (01)04987892028977(11)200529(17)250430(10)2005295X6
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091641
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-00304HHTA
• Device Lot Number: 2005295X6
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• 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