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

Model Number	7118-2048
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	03/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The hydrocoil embolic system (hes) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.The hes is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.Per the instructions for use: potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.This device involved in this event has not yet been returned for evaluation.Upon examination of the sample/completion of the investigation, a follow-up medwatch will be submitted.(b)(4).
Event or Problem Description
It was reported that during the treatment of a fistula, a portion of the coil prematurely detached within the catheter while positioning.The remainder of the coil was pushed into the intended site successfully.No patient harm or injury was reported.
Additional Manufacturer Narrative
Based on the investigation findings the customer complaint is confirmed.The root cause of this complaint is likely due to the device being exposed to a force that exceeded the maximum tensile specification.Reference mvi: (b)(4).Missing information from this report is identified as a blank, unknown and as no information (ni); this information was not provided in the reported event or available at the time of report submission.

• Brand Name: HYDROFRAME 18 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5545024
• Report Number: 2032493-2016-00059
• Device Sequence Number: 383885
• Product Code: HCG
• UDI-Device Identifier: 00811425029862
• UDI-Public: (01)00811425029862(11)150917(17)200917(10)150917V6
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2016

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: 09/17/2020
• Device Model Number: 7118-2048
• Device Lot Number: 150917V6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Supplement Report FDA Received Date: 06/03/2016
• 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: 64 YR