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

Catalog Number MX5060

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

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter telephone number: (b)(6).This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a customer indicated the balloon of a 5f mynx control vascular closure device (vcd) caught on calcium and ruptured during pulling back to the arteriotomy.There was no reported patient injury.The physician attempted to deflate the balloon a little bit to allow it to more easily pass through the calcified segment.His was apparently unsuccessful and the balloon rupture eventually occurred.The device was used in an interventional procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was moderate presence of pvd / calcium in the vicinity of the puncture site.Hemostasis was achieved by manual compression for less than 30 minutes.The device was stored and prepped according to the ifu.The device is being returned for evaluation.

Manufacturer Narrative

As reported, a customer indicated the balloon of a 5f mynx control vascular closure device (vcd) caught on calcium and ruptured during pulling back to the arteriotomy.There was no reported patient injury.The physician attempted to deflate the balloon a little bit to allow it to pass through the calcified segment more easily.This was apparently unsuccessful and the balloon rupture eventually occurred.The device was used in an interventional procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was moderate presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.Hemostasis was achieved by manual compression for less than 30 minutes.The device was stored and prepped according to the ifu.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 was depressed 1/3 of its total travel and button 2 was not depressed.The syringe was received connected to the stopcock of the device, and an unknown procedural sheath was locked onto the sheath catch.Blood was noted in the procedural sheath with no damages on it.The stopcock was observed opened, and the balloon was found fully deflated.In addition, the sealant was found fully exposed from the sealant sleeves, which were observed to have been severely kinked/bent.The sealant was covering the balloon neck as received and exposed to blood.Per functional analysis, an inflation/deflation test could not be performed on the returned device since evidence of crystallized residual fluid in the inflation tubing was noted.Multiple attempts were made to clear the blockage in the device inflation lumen with water without success.Per microscopic analysis, visual inspection at high magnification revealed the balloon was observed fully deflated and the sealant was noted covering the balloon neck as received and exposed to blood.The sealant was found fully exposed from the sealant sleeves, which were observed to have been severely kinked/bent.In addition, as the inflation/deflation test could not be performed, the microscopic examination was performed to the balloon of the received device, and it revealed a longitudinal tear.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device due to the longitudinal tear found on the balloon.However, the exact cause of the tear found could not be conclusively determined during analysis.Based on the information available for review and product analysis, access site vessel characteristics (the balloon reportedly ruptured on calcium and there was moderate pvd/calcium within the vicinity of the puncture site) most likely contributed to the reported event since this type of tear is typically observed when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent, or vascular graft).According to the ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, the device preparation states to discard the device if the balloon does not maintain pressure.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: 18684064
• MDR Text Key: 335091873
• Report Number: 3004939290-2024-00066
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5060
• Device Lot Number: F2223503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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: 5F TERUMO SHEATH