MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	MC162156S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/13/2020
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.The device was not returned to the manufacturer for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies vessel dissection as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of an aneurysm in a tortuous right posterior inferior cerebellar artery (pica), a possible vessel dissection was identified.There was no reported additional intervention or clinical sequela.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9729982
• Report Number: 2032493-2020-00037
• Device Sequence Number: 13988244
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)190611(17)220531(10)19061111Q
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: MC162156S
• Device Catalogue Number: MC162156S
• Device Lot Number: 19061111Q
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR