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

Model Number 7110-0304-3D-A2

Device Problem Component Missing (2306)

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

Event Date 08/21/2023

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 stated to be available for return to the manufacturer, but it has not yet been received.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted with the evaluation results.

Event Description

It was reported that an embolization coil implant was missing from the packaging hoop.There was no patient involvement, injury, or intervention.

Manufacturer Narrative

The visual analysis of the returned items found that the introducer was kinked at the distal section, and the distal tip was damaged, the pusher heater coil was damaged, and the implant was not attached to the pusher.The investigation of the pusher found the monofilament broken, which indicates the device experienced a tensile break.It was stated in the complaint that during the pre-preparation process, the device did not have the coil in the hoop; however, the build record associated with this specific lot number showed that the quality verification confirmed that the implant was present and attached to the pusher during the final inspection process prior to the device being released.Investigation conclusion: the reported complaint is unconfirmed.The investigation of the returned coil system found the introducer kinked at the distal section, and damaged at the distal tip.Further inspection found the pusher heater coil damaged, and the implant was not attached to the pusher.The implant was reported missing in the event; however, the build record for this lot number indicates the device had the implant attached to the pusher and met the specification prior to releasing the packaged device.Since the pusher's monofilament showed a tensile break shape at the tip, this indicates that the device experienced excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the observed damage, but the damage is consistent with the device experiencing forces over specification.

Event Description

See section h10 for investigation results.

• 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: 17695077
• MDR Text Key: 322840295
• Report Number: 2032493-2023-00926
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025456
• UDI-Public: (01)00816777025456(11)220715(17)270630(10)0000231083
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7110-0304-3D-A2
• Device Lot Number: 0000231083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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