MAUDE Adverse Event Report: HEADWAY DUO MICROCATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	MC162156S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded and not returned to the manufacturer for evaluation; therefore, the alleged product issue cannot be confirmed.The onyx instruction for use (ifu) identifies delivery catheter removal difficulty as potential complications associated with use of the device.Warnings include: premature solidification of onyx may occur if micro catheter luer contacts saline, blood or contrast of any amount.Do not exceed 0.3 ml/min injection rate.Animal studies have shown that rapid injection of dmso into the vasculature may lead to vasospasm and/or angionecrosis.Do not allow more than 1 cm of onyx to reflux back over catheter tip.Excessive onyx reflux may result in difficult catheter removal.Stop injection if increased resistance to onyx injection is observed.If increased resistance occurs, determine the cause (e.G., onyx occlusion in catheter lumen) and replace the catheter.Do not attempt to clear or overcome resistance by applying increased injection pressure, as use of excessive pressure may result in catheter rupture and embolization of unintended areas.Do not interrupt onyx injection for longer than two minutes prior to re-injection.Solidification of onyx may occur at the catheter tip resulting in catheter occlusion, and use of excessive pressure to clear the catheter may result in catheter rupture.
Event or Problem Description
It was reported that upon removal of the catheter from the intended embolization site in the patient's left middle meningeal artery (mma), onyx leaked out of the catheter causing the catheter to stretch and snap off.A piece of the microcatheter was retained inside the patient's artery.There was no reported patient injury.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• MDR Report Key: 12256991
• Report Number: 2032493-2021-00303
• Device Sequence Number: 5001887
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)201216(17)231130(10)20121652J
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: MC162156S
• Device Catalogue Number: MC162156S
• Device Lot Number: 20121652J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Weight: 51