MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT ADVANCED; EMBOLIZATION COIL

Model Number MV-00203HHSA

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

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

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicate the lot met all release criteria.A lot history trending review was performed and there are no similar complaints for this lot number.The device was not returned to the manufacturer; therefore, an evaluation could not be performed.The root cause is unknown.

Event Description

It was reported that during placement of an embolization coil, an attempt was made to withdraw the coil back into the microcatheter to "re-coil" it; however, the coil would not move.The coil was pulled against resistance until it detached.A snare was used to pull the detached segment up into the internal carotid artery and the procedure was completed.The detached coil segment remains in the ica.The patient was reported to have no health damage.

• Brand Name: HYDROSOFT ADVANCED
• 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: 6265719
• MDR Text Key: 65344547
• Report Number: 2032493-2017-00022
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350987051
• UDI-Public: (01)04987350987051(11)151123(17)201123(10)15112349
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2016

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: 11/23/2020
• Device Model Number: MV-00203HHSA
• Device Lot Number: 15112349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• 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
• Patient Outcome(s): Required Intervention