MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-DUO 16; ACCESS DEVICES

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the physicians had previous cases of the tip of the headway in embolizations with onyx.No lot or model or additional information has been provided to date.

Manufacturer Narrative

The device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The breakage issue could not be confirmed.The instructions for use (ifu) identifies catheter breakage as potential complications associated with use of the device.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.

• Brand Name: HEADWAY-DUO 16
• Type of Device: ACCESS DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 93446
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 93456 ; 7142478000
• MDR Report Key: 16502783
• MDR Text Key: 310951195
• Report Number: 2032493-2023-00602
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other