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

Model Number MC162167S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Rupture (2208)

Event Date 03/16/2021

Event Type  Injury  

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.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.

Event Description

It was reported that an embolization of a left aica-avm was performed successfully with headway duo and phil 25%.When withdrawing the headway duo, the basilar artery ruptured.The cause of the rupture is not known.The physician stated that there was some tension on the headway duo, possibly caused by tortuous anatomy.The patient underwent successful surgery for pressure relief and is in intensive care.

• Brand Name: HEADWAY DUO MICROCATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11682727
• MDR Text Key: 248147936
• Report Number: 2032493-2021-00137
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)200930(17)230831(10)200930538
• Combination Product (y/n): N
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MC162167S
• Device Catalogue Number: MC162167S
• Device Lot Number: 200930538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 75