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

Model Number 101440HFIL-V

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

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 been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that during placement of an embolization coil in an aneurysm, resistance was encountered.During removal, the coil unexpectedly detached in the microcatheter, with part of the coil in the aneurysm.Both segments of the coil were removed along with the microcatheter from the patient.There was no reported intervention or patient injury.The patient's status is reported to be doing well.

Manufacturer Narrative

The device was returned with the implant detached and noted to be stretched from the proximal section.The pusher had a lead wire separated from the core wire.The body coil was noted to be kinked at several locations.The monofilament had a tail and striations, indicating a tensile stretch.Based on the investigation and provided information, the complaint can be confirmed.The specific root cause of this complaint is unknown; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: HYDROFILL HELICAL
• 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: 6836722
• MDR Text Key: 84645022
• Report Number: 2032493-2017-00224
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K113457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2017

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: 08/31/2018
• Device Model Number: 101440HFIL-V
• Device Lot Number: 13082603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 08/06/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2013
• 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: 68 YR