MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; EMBOLIZATION COIL

Model Number 100208H2HS-V-A2

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device was returned for evaluation.The pusher heater coil was observed to be compressed and deformed and the implant coil was detached; however, the root cause could not be determined.

Event Description

It was reported that during a coil embolization treatment of a para-opthalmic aneurysm, the coil unexpectedly detached in the hub of the microcatheter.Both segments of the coil were removed in their entirety.There was no reported intervention or patient injury.The patient's current status is reported to be fine.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780
• MDR Report Key: 6655099
• MDR Text Key: 78138682
• Report Number: 2032493-2017-00146
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022905
• UDI-Public: (01)00816777022905(11)170412(17)220331(10)170412W4
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 100208H2HS-V-A2
• Device Lot Number: 170412W4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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 Age: 42 YR