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

Model Number 100410HC-S-V-A1-CN

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not yet been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that an embolization coil did not advance in the distal portion of the microcatheter.During removal, the coil unexpectedly detached in the aneurysm.There was no reported intervention or patient injury.The patient's status is reported to be fine.

• Brand Name: MICROPLEX HELICAL SOFT
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 6819650
• MDR Text Key: 83631866
• Report Number: 2032493-2017-00211
• Device Sequence Number: 1
• Product Code: HGC
• UDI-Device Identifier: 00812636024592
• UDI-Public: (01)00812636024592(11)161004(17)210930(10)161004W2
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131948
• 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: 07/27/2017

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: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: 100410HC-S-V-A1-CN
• Device Lot Number: 161004W2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2016
• 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 Age: 62 YR
• Patient Weight: 70