MAUDE Adverse Event Report: CARDINAL HEALTH MYNX GRIP, DEVICE HEMOSTASIS, VASCULAR; VASCULAR CLOSING DEVICE

Model Number MX5021

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  Injury  

Event Description

A 5fr mynx collagen was out of the deliver system.

• Brand Name: MYNX GRIP, DEVICE HEMOSTASIS, VASCULAR
• Type of Device: VASCULAR CLOSING DEVICE
• Manufacturer (Section D): CARDINAL HEALTH; santa clara CA
• MDR Report Key: 7317022
• MDR Text Key: 101776046
• Report Number: MW5075706
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: MX5021
• Device Lot Number: F1734602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR