MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS 18 VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 181859CS-V-A2

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 has not yet been returned to the manufacturer for analysis.(b)(4).

Event Description

It was reported that the product information on the outer box label did not match the product information on the inner pouch label.The device was not used in the patient.

Manufacturer Narrative

Investigation of the returned packaging and device revealed that rework was performed at the fedex warehouse in netherlands to replace damaged outer carton boxes.Replacement boxes and box labels for two devices were sent as part of the rework order.It was determined that the boxes and pouches were inadvertently interchanged during the rework process at fedex.

• Brand Name: MICROPLEX COSMOS 18 VTA
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10909581
• MDR Text Key: 222122672
• Report Number: 2032493-2020-00351
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777024145
• UDI-Public: (01)00816777024145(11)170928(17)220831(10)1709281W7
• Combination Product (y/n): N
• PMA/PMN Number: K102365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 181859CS-V-A2
• Device Lot Number: 1709281W7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1