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

Model Number	100728HFRM-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6359610
• Report Number: 2032493-2017-00044
• Device Sequence Number: 16285181
• Product Code: HCG
• UDI-Device Identifier: 00811425027141
• UDI-Public: (01)00811425027141(11)160203(17)210203(10)160203F1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/03/2021
• Device Model Number: 100728HFRM-V-A
• Device Lot Number: 160203F1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR