MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-18-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 181036CS-V-A1-CN

Device Problem Component Missing (2306)

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

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 analysis and its evaluation is ongoing.

Event Description

It was reported that when the embolization coil was advanced into the microcatheter, the physician noted the coil was missing.No patient injury was reported.Reportedly, the physician did not inspect the coil prior to use.

Manufacturer Narrative

Additional information: h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the pusher's body coil damaged at distal, the introducer distal tip damaged, and the implant separated from the pusher.Further investigation found the coil implant stuck inside the dispenser hoop.No indication using a detachment controller was found on the pusher's heater coil.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.

• Brand Name: COSMOS-18-AV
• Type of Device: NEUROVASCULAR 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: 14122157
• MDR Text Key: 290304976
• Report Number: 2032493-2022-00140
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636026138
• UDI-Public: (01)00812636026138(11)210728(17)260630(10)2107285U1
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 181036CS-V-A1-CN
• Device Lot Number: 2107285U1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 66 KG