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

Model Number 102050CC-V

Device Problems Premature Activation (1484); Difficult to Remove (1528); Stretched (1601); Positioning Problem (3009)

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

Event Date 09/17/2014

Event Type  Injury  

Event Description

Coiling treatment was conducted of an aneurysm.It was reported that the coil appeared to have stretched during positioning of the microcatheter.Upon removal of the device, the coil prematurely detached in the microcatheter.The coil was successfully removed within the microcatheter.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 COMPLEX 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: 4360239
• MDR Text Key: 5234994
• Report Number: 2032493-2014-00111
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/12/2019
• Device Model Number: 102050CC-V
• Device Lot Number: 1C02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2014
• 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: 50 YR
• Patient Weight: 65