MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 18 ADVANCED; EMBOLIZATION COIL

Model Number MV-80827HHFA

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

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 was not returned for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.

Event Description

It was reported that the coil did not frame inside the aneurysm.Resistance was encountered as the coil was withdrawn into the microcatheter.The coil detached in the microcatheter.The coil was removed in its entirety with the microcatheter.There was no reported intervention, patient injury, or health damage.

• Brand Name: HYDROFRAME 18 ADVANCED
• 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: 7235864
• MDR Text Key: 98998592
• Report Number: 2032493-2018-00019
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100454
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: MV-80827HHFA
• Device Lot Number: 14101449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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