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

Model Number 182065CS-V

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2016

Event Type  malfunction  

Manufacturer Narrative

The coil was returned without the detached distal coil segment.The microcatheter was not returned; therefore, testing could not be performed to evaluate the dimensional compatibility of the device with the coil.The pusher wire was noted to be kinked in several locations along the length, including the gold connector.Lead wire separation was also noted proximal to the warning mark.The body coil and pet were smashed just distal to the heater coil, twisting and damaging the lead wires.The solder joints appeared intact.The monofilament rebound was measured to be 0.175".The monofilament has a tail end that measures 0.006".The device exhibited evidence of excessive stress to the monofilament.Based on the evaluation of the returned coil segment and the information provided, the event most likely occurred as a result of multiple coil manipulations during the attempts to advance the coil through the microcatheter.

Event Description

It was reported that during the procedure, an embolization coil would no longer advance in the microcatheter.The coil and the microcatheter were removed together as a single unit from the patient.After the devices were removed, the coil was noted to have detached and the distal coil segment still remained in the vessel.Another microcatheter and a solitaire stent coil retriever were used to remove the coil segment from the patient.There were no reported clinical sequelae.The patient's current status is reported to be "fine.".

• Brand Name: MICROPLEX COSMOS
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: sandra valencia ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6252930
• MDR Text Key: 64907321
• Report Number: 2032493-2017-00020
• Device Sequence Number: 1
• Product Code: HCG
• 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: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: 182065CS-V
• Device Lot Number: 141210A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 50