MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SOFT; ARTIFICIAL EMBOLIZATION DEVICE

Model Number MV-00817HHTA

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

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 in a tangle; the pusher, lead wires, and implant were all tangled together.The proximal area of the implant was also stretched.The introducer was sheathing the gold connector.The tip was damaged and the middle-to-proximal portion was broken off and missing.The core wire of the pusher was kinked 55.7 cm distal to the proximal end of the pusher, or approximately 129 cm from the distal tip of the pusher.Lead wire separation is observed throughout the pusher.The gold connector is slightly bent.The warning mark was found butted against the distal end of the gold connector.The warning mark should be found approximately 147 - 149 cm away from the distal tip of the pusher.The warning marking pet is able to slide up and down the proximal side of the pusher.Based on the investigation the complaint is confirmed because the warning mark was found next to the gold connector.The warning mark pet, with some resistance, is able to slide around on the pusher core wire and most likely moved towards the gold connector end when the pusher was advanced in the introducer.The cause is consistent with the warning mark pet not being completely heat shrunk to the core wire.Unshrunk warning marks is an issue that is tracked by quality for this product.

Event Description

It was reported that prior to the proximal coil "zebra" marker reaching the y-valve port, the coil was exposed from the introducer.There was no reported patient injury or additional intervention.The patient is reported to be "fine.".

• Brand Name: MICROPLEX HELICAL SOFT
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9941815
• MDR Text Key: 191595758
• Report Number: 2032493-2020-00093
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777028464
• UDI-Public: (01)00816777028464(11)181030(17)230930(10)1810305VL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: MV-00817HHTA
• Device Lot Number: 17090454K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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: 70 YR
• Patient Weight: 65