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

Catalog Number MX6760E

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

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

Event Date 03/08/2024

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) burst during prep.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There were no visible signs of device/package damage prior to use.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu) instructions.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 verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd used in percutaneous coronary intervention (pci) with a retrograde approach made.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) burst during prep.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There were no visible signs of device/package damage prior to use.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu) instructions.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 verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd used in percutaneous coronary intervention (pci) with a retrograde approach made.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.A non-sterile ¿mynx control vcd 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe and the procedural sheath were not received for evaluation.The stopcock was observed in the open position, and the balloon was found fully deflated.In addition, the sealant was found in its manufactured position, fully covered by the sealant sleeves.The sealant was not exposed to blood.In addition, no damages were observed to sealant sleeves assembly.Per functional analysis, the inflation/deflation test was conducted in accordance with the mynx control ifu, and a leak in the balloon of the returned device was exposed.Per microscopic analysis, upon visual examination at high magnification, a longitudinal tear was detected on the balloon of the returned device.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear found could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is difficult to determine what factors may have contributed to the issue reported.However, as this issue was found during preparation of the device, handling factors during prep are likely.According to the ifu during the prepare balloon step, which is not intended as a mitigation, ¿fill locking syringe with 2 to 3 ml of sterile saline, attach to stopcock and draw vacuum.Check luer connector and tighten if necessary.Inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.¿ neither the product analysis, nor the information available for review suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• 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: 19096658
• MDR Text Key: 340808807
• Report Number: 3004939290-2024-00176
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: F2325704
• 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
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/12/2024
• Date Device Manufactured: 09/14/2023
• 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: 6F TERUMO SHEATH