MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) ruptured and couldn't be used.Hemostasis was achieved with manual compression for twenty-five minutes, resulting in no extended hospitalization.There was no reported patient injury.The device was used during a transarterial chemo-embolization (tace) using a retrograde approach, and the physician was being trained on its use.A 6f non cordis sheath was used.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use.The vessel type was femoral arterial, and its diameter was verified to be greater than 5 mm.There was severe vessel tortuosity and severe presence of pvd / calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was prepped according to the instructions for use (ifu).The device will be returned for evaluation.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 19080872
• MDR Text Key: 340117190
• Report Number: 3004939290-2024-00169
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MX6760E
• Device Lot Number: F2322703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• 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
• Treatment: TERUMO 6F RADIFOCUS 2 INTRODUCER
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian