MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS; EMBOLIZATION COIL

Model Number 100412CSSR-V-A

Device Problems Detachment Of Device Component (1104); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not yet been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that during a balloon assisted treatment for a posterior communicating artery aneurysm, resistance was encountered while attempting to enter the intended area.During removal of the coil, the coil detached in the microcatheter.The coil was removed together with the microcatheter.There was no reported intervention or patient injury.The patient is reported to be doing well.

Manufacturer Narrative

The device was returned without the implant.The pusher was noted to be stretched proximal to the heater coil.The leadwires were broken from the stretched zone.The distal solders were noted to be intact.The monofilament had striations and a tail, which confirmed a tensile pull.Based on the investigation and provided information, the complaint can be confirmed.The specific root cause of this complaint is unknown; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: MICROPLEX COSMOS
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 6847354
• MDR Text Key: 85617431
• Report Number: 2032493-2017-00230
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425025758
• UDI-Public: (01)00811425025758(11)161107(17)211031(10)161107V2
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 100412CSSR-V-A
• Device Lot Number: 161107V2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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: 56 YR
• Patient Weight: 55