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

Catalog Number MX6760E

Device Problems Premature Activation (1484); Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 03/19/2024

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 during the maneuver of pulling the balloon through the calcified vessel.Subsequently, the procedure was successfully completed using another mynx control vcd.There was no reported patient injury.The device had been stored and prepared in accordance with the instructions for use (ifu).The balloon lost pressure slightly after being pulled to the arteriotomy.However, before losing pressure fully, the operator was able to check the leakage from the balloon in the angiography.Upon confirming the leakage, the device was promptly removed without utilizing the buttons.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 6f non-cordis vascular sheath introducer.The vessel diameter was confirmed to be equal to or greater than 5 mm.There was moderate vessel tortuosity.There was severe presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The procedure involved an interventional peripheral procedure with a retrograde approach.The operator held certification for using the mynx device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: based on preliminary review of the returned device received for decontamination, the sealant was exposed to blood and exposed from the sealant sleeves.

• 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: 19118155
• MDR Text Key: 340695335
• Report Number: 3004939290-2024-00188
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX6760E
• Device Lot Number: F2400505
• 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: 03/25/2024
• Date Device Manufactured: 02/01/2024
• 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: 6F TERUMO RADIFOCUS INTRODUCER 2 SHEATH; ANOTHER UNKNOWN MYNX CONTROL
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian