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

Model Number MV-02506HHSA

Device Problems Detachment Of Device Component (1104); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2015

Event Type  malfunction  

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.The device involved in the event will not be returned for evaluation.The complaint cannot be confirmed.(b)(4).

Event Description

It was reported during the coiling treatment of an aneurysm, resistance was encountered as the embolization coil was advanced within the catheter.Upon withdrawal, the coil prematurely detached within the microcatheter.The entire system (catheter and coil) was removed from the patient successfully.No patient injury reported.

• Brand Name: HYDROSOFT ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: bill wiggins ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 5076145
• MDR Text Key: 25774007
• Report Number: 2032493-2015-00142
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: MV-02506HHSA
• Device Lot Number: 15012849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1