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

Model Number 100256HS-V-A

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

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

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) is being reviewed.The device has not yet been returned to the manufacturer.The investigation is currently underway.

Event Description

It was reported that during positioning of an embolization coil in an aneurysm, resistance was encountered and the coil unexpectedly detached from the pusher wire in the microcatheter.The detached distal coil segment was retrieved with a snare device.There was no reported patient injury.The current patient's status is reported to be good.

Manufacturer Narrative

The device was returned with no dispenser coil or introducer.The separated hypotube, along with the remainder proximal section, was not returned for evaluation.The pusher coil was noted to be completely broken from the transition zone.On the distal side, part of the implant coil was noted to be stretched out from the proximal tie knot location, and completely broken.The remaining implant coil along with the marker band was still attached to the pusher, with good tension in the monofilament.The distal black pet covering the heater coil had no signs of thermal damage.The returned product evaluation confirmed a broken coil.The reported event details indicated that the coil became detached during repositioning.The exact root cause cannot be determined; however, the device exhibits evidence that it was subjected to forces that exceeded its tensile strength specifications.The device was used during the same procedure as was reported in mfr report# 2032493-2017-00008.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• 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 ; 7142478000
• MDR Report Key: 6375336
• MDR Text Key: 68964884
• Report Number: 2032493-2017-00050
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K132952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: 100256HS-V-A
• Device Lot Number: 141231V2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 55