MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COMPASS COMPLEX VTA; ARTIFICIAL EMBOLIZATION DEVICE

Model Number 180308HC-S-V-A2

Device Problem Component Missing (2306)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that while embolizing a patient there was no microplex helical soft vta coil in the microplex system casing.No patient impact was reported.

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 evaluation but has not yet been returned.If the device is received the investigation will be performed and a supplemental report will be submitted.

Manufacturer Narrative

The investigation of the returned coil system found the hypotube bent, the body coil kinked, and the implant not attached to the pusher.No indication using a detachment controller was found on the pusher's heater coil.However, further inspection found that the implant was stuck inside of the dispenser hoop.The investigation 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 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: MICROPLEX COMPASS COMPLEX VTA
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14270275
• MDR Text Key: 293360810
• Report Number: 2032493-2022-00185
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022127
• UDI-Public: (01)00816777022127(11)200722(17)250630(10)2007221WE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180308HC-S-V-A2
• Device Lot Number: 2007221WE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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