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

Model Number	MC162156S
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances 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.Investigation of the catheter found dried onyx embolic at the hub, a kink along the shaft of the catheter, and a broken distal tip consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that during a middle meningeal artery (mma) embolization with onyx liquid embolic, the tip of the headway duo catheter got stuck in the onyx cast and broke off in the right mma due to excess reflux along the catheter than intended.The broken piece was left in the patient.The right mma branch was totally blocked off as expected and physician continued to embolize the left mma and procedure completed without any issues.Reportedly, the patient woke up fine.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• MDR Report Key: 12453869
• Report Number: 2032493-2021-00373
• Device Sequence Number: 11641972
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)210518(17)240430(10)21051856B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 04/30/2024
• Device Model Number: MC162156S
• Device Catalogue Number: MC162156S
• Device Lot Number: 21051856B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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