MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL HELICAL COIL; EMBOLIZATION COIL

Model Number MV-00620HFL

Device Problems Detachment Of Device Component (1104); Stretched (1601); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Coiling treatment was conducted of an aneurysm.It was reported that the coil did not detach.Upon retraction of the device, the coil stretched.Subsequently, the proximal end of the delivery pusher was cut and torqued to mechanically detach the coil.During this attempt, the device broke.A guidewire was used to push the coil and portion of the delivery pusher in the aneurysm.A segment was not contained in the aneurysm initially.The procedure was resumed and completed successfully.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: HYDROFILL HELICAL 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: 4339954
• MDR Text Key: 5178348
• Report Number: 2032493-2014-00105
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/10/2019
• Device Model Number: MV-00620HFL
• Device Lot Number: 14071049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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