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

Model Number 100510CMSR-V

Device Problems Detachment Of Device Component (1104); Separation Failure (2547); Device-Device Incompatibility (2919)

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

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer.The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.The investigation is currently underway.

Event Description

It was reported that after placement in an aneurysm, an embolization coil failed to detach with more than one v-grip controller.The decision was made to remove the coil.After retracting the coil a few centimeters, the coil became stuck in the microcatheter and, after multiple manipulations, detached accidentally.The pusher wire was removed from the microcatheter.A gooseneck snare was used to capture the detached distal coil segment from the aneurysm and was withdrawn from the patient together with the microcatheter and the snare without further incident.There were no clinical consequences.The patient's current condition is reported to be "fine.".

• Brand Name: MICROPLEX COMPASS COMPLEX
• 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: 6248506
• MDR Text Key: 64711293
• Report Number: 2032493-2017-00015
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

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: 10/30/2021
• Device Model Number: 100510CMSR-V
• Device Lot Number: 14032613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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