MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-10-AV; EMBOLIZATION COIL

Model Number 100306CSSR-V-A1-CN

Device Problem Component Missing (2306)

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

Event Date 11/15/2022

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 to the manufacturer for evaluation.The investigation is ongoing.

Event Description

It was reported that an embolization coil implant coil was missing and not attached to the pusher wire out of the package.There was no patient involvement.

Event Description

It was reported that an embolization coil implant coil was missing and not attached to the pusher wire out of the package.There was no patient involvement.

Manufacturer Narrative

The investigation of the returned coil system found the proximal connector kinked and the implant severely stretched and broken at the proximal end, but still attached to the pusher.The distal portion of the implant was not returned for evaluation.The implant's monofilament showed 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 stretch and break.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: COSMOS-10-AV
• Type of Device: EMBOLIZATION COIL
• 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: 16279739
• MDR Text Key: 308624374
• Report Number: 2032493-2023-00544
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636025483
• UDI-Public: (01)00812636025483(11)211105(17)261031(10)0000117617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100306CSSR-V-A1-CN
• Device Catalogue Number: 7110-0310
• Device Lot Number: 0000117617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2021
• 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: 72 YR