MAUDE Adverse Event Report: MICROVENTION, INC. 100728HFRM-V-A; EMBOLIZATION COIL

Model Number 100728HFRM-V-A

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Stretched (1601)

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

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned to the manufacturer.The lot number was provided and the device history records are being reviewed.The investigation is currently underway.

Event Description

It was reported that during the treatment of a pseudoaneurysm of the right internal iliac artery, the embolization coil was positioned in place.Upon detachment, the coil did not detach.The device was pulled to withdrawal, however the delivery pusher stretched and broke.A portion of the stretched delivery pusher segment was removed, but the other portion remained in the vessel.The patient was reported to be okay.Additional information/clarification received on 4 feb 2017, indicated the following: the embolization coil was within the aneurysm.Attempts were made to remove the device by pulling.It was stated that the physician pulled the device very hard.These attempts were unsuccessful.The stretched portion of the device (delivery pusher) was left in place, no other intervention was taken.It was reported that the physician emphasized that he tried to remove the device with too much force.It was indicated that it was not the fault of the device.The patient was reported to be okay with no negative consequences.

• Brand Name: 100728HFRM-V-A
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: sandra valencia ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6359610
• MDR Text Key: 68375423
• Report Number: 2032493-2017-00044
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425027141
• UDI-Public: (01)00811425027141(11)160203(17)210203(10)160203F1
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050954
• 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: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/03/2021
• Device Model Number: 100728HFRM-V-A
• Device Lot Number: 160203F1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR