MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT 3D COIL; EMBOLIZATION COIL

Model Number 100203HS3D-V

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/05/2014

Event Type  Injury  

Event Description

Coiling treatment was conducted of an aneurysm.It was reported that the coil did not detach.Upon removing the device, the coil prematurely detached.The coil was removed with the micro-catheter successfully.No injury was reported with the patient as a result of the procedure.

Manufacturer Narrative

Sample analysis: the device has been received and is pending evaluation completion.The root cause of this complaint cannot be determined at this time.Evaluation findings will be submitted in a follow-up report.(b)(4).

• Brand Name: MICROPLEX HYPERSOFT 3D COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA
• Manufacturer Contact: teri halverson ; 1311 valencia; tustin, CA 92780 ; 7142478000
• MDR Report Key: 4360170
• MDR Text Key: 17935224
• Report Number: 2032493-2014-00119
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 11/25/2019
• Device Model Number: 100203HS3D-V
• Device Lot Number: 141125V5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 56