MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER

Model Number MC162167S

Device Problems Leak/Splash (1354); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment, not diagnosis.The headway duo microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature.The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels.Radiopaque marker(s) at the distal end facilitate fluoroscopic visualization.The outer surface of the microcatheter is coated with a hydrophilic polymer to increase lubricity.A luer fitting on the microcatheter hub is used for the attachment of accessories.Indications for use the headway duo microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.The headway duo microcatheter is intended for neurovascular use, for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the headway duo microcatheter.Warnings the microcatheter should only be used by physicians who are familiar with angiographic and interventional procedures.It is important to follow the instructions for use prior to using this product.The microcatheter is provided sterile and non-pyrogenic unless the unit package is opened or damaged.Do not use if the packaging is breached or damaged.The microcatheter is intended for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.After use, dispose device in accordance with hospital and/or local government policy.Inspect the microcatheter prior to use for any irregularities or damage and discard if any inconsistencies are observed.The microcatheter should be advanced or manipulated under fluoroscopic guidance.Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Infusion pressure should not exceed 700 psi to avoid potential rupture of the microcatheter.Shaping mandrel is not intended for use inside the body.Ensure shaping mandrel is removed from microcatheter prior to introduction into the rhv or other accessories.Based on the investigation findings, the complaint is confirmed as there was damage at the distal end of the device tip.The root cause is likely due do the reported reflux.Mvi: p16-0735.

Event Description

It was reported that during a dural arteriovenous fistula (davf), onyx 34 injection was performed.Noted reflux around catheter tip was reported.Upon removal of the catheter it was observed that the catheter tip had torn.No harm or injury occurred as a result of this incident.

• Brand Name: HEADWAY DUO MICROCATHETER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia ave; tustin CA 92780
• Manufacturer (Section G): MICROVENTION, INC; 1311 valencia ave; tustin CA 92780
• Manufacturer Contact: bill wiggins ; 1311 valencia ave; tustin, CA 92780 ; 7142478000
• MDR Report Key: 5507745
• MDR Text Key: 40581177
• Report Number: 2032493-2016-00048
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)151221(17)181221(10)15122124
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/21/2015
• Device Model Number: MC162167S
• Device Lot Number: 15122124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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 Age: 46 YR
• Patient Weight: 76