MAUDE Adverse Event Report: CORDIS US CORP. MYNX VASCULAR CLOSURE DEVICE; DEVICE, HEMOSTASIS, VASCULAR

Model Number MX5060

Device Problem Fracture (1260)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

Patient presented to interventional radiology with traumatic hemorrhage requiring hepatic arterial embolization.During procedure the mynx device was opened however noted to be fractured and unusable.Device was removed and a new device was utilized with successful hemostasis.This is the second device in this lot that we have reported for failure.

• Brand Name: MYNX VASCULAR CLOSURE DEVICE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS US CORP.
• MDR Report Key: 17031603
• MDR Text Key: 316324866
• Report Number: MW5117991
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX5060
• Device Catalogue Number: MX5060
• Device Lot Number: F2305301
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American