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

Model Number 100825CSSR-V

Device Problem Premature Activation (1484)

Patient Problem Rupture (2208)

Event Date 12/02/2014

Event Type  Injury  

Event Description

Coiling treatment was conducted of a ruptured posterior communicating aneurysm.It was reported that during positioning, the coil prematurely detached.The coil was removed with the microcatheter successfully.It was then reported that the physician re-advanced the coil back in the microcatheter into the aneurysm successfully.The case was completed using 4 additional coils.No injury was reported with the patient as a result of the procedure.

Manufacturer Narrative

Sample analysis: the device is reported to be available.However, it has not been received to date.The root cause of this complaint cannot be determined at this time.An evaluation will be performed once the device is returned.(b)(4).

• Brand Name: MICROPLEX COSMOS 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: 4360181
• MDR Text Key: 21567236
• Report Number: 2032493-2014-00115
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 12/02/2014

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: 01/29/2019
• Device Model Number: 100825CSSR-V
• Device Lot Number: 14012913
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 86