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

Catalog Number MX6760E

Device Problem Premature Activation (1484)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

The sealant protection of a 6f/7f mynx control vascular closure device (vcd) was severely cracked, so the sealant first met the blood and reacted.Therefore, the product wasn¿t available and another unknown mynx control device was used and "recovered".The mynx vcd was used in a used in transarterial chemoembolization (tace) procedure.There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Also, the mynx vcd was stored and prepped according to the ifu.The procedure used a retrograde approach.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 5mm in diameter.The puncture site did not have visible calcium/plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site, however the was little tortuosity of the vessel.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.There were no reports of patient injury.The device was retuned for analysis.A non-sterile ¿mynx control vascular closure device 6/7f¿ 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 with stopcock open.The sealant sleeve assembly were observed to have been kinked/bent as received, however no cracks were observed on it.Additionally, the sealant sleeves were not fully covering the sealant.The sealant was found swelled from exposure to blood.No damage was observed in the atraumatic tip of the returned device.The syringe and the procedure sheath were not returned with the device.Dimensional analysis was performed to verify the slit length measurement.The slit length was verified against the specification.Dimensional analysis results were found out of specification.Simulated deployment test was performed on the returned device per the mynx control instructions for use (ifu), lbl10152_rev 4, button 1 was able to be fully depressed and locked in place with some resistance felt.It was revealed that the sealant was exposed to blood which caused the resistance felt when attempted to depress the button 1.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Visual inspection at high magnification (eq4440-01) showed that the sealant remained in the manufacturing position, exposed to blood.The sealant sleeve assembly was observed to have been kinked/bent as received, however no cracks were observed on it.Additionally, the sealant sleeves were not fully covering the sealant.The sealant was found swelled from exposure to blood.In addition, microscopic examination showed that the slit length measurement was 16 mm.The reported ¿mynx control sealant sleeves ~ cracked-in patient¿ was not confirmed since no cracks were found in the sealant sleeve assembly, however, visual inspection of the returned device revealed that the sealant sleeve assembly was kinked/bent, which may have contributed to the reported incident.The reported ¿mynx control system- deployment difficulty-premature¿ was confirmed.However, the exact cause for this incident could not definitely be determined from the information provided.It should be noted that mynx control device is manufactured with the sealant sleeve assembly at the distal end of the catheter cartridge tubing.The sealant sleeve assembly is assembled with 2 side slit overlapping sleeves.Please note that the slits in the sealant sleeve assembly are not a product defect.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the sealant sleeve assembly and is protected by the sealant sleeve assembly from being exposed prematurely.If the sealant sleeve is damaged/kinked during the device insertion into sheath, that could cause the sealant exposed/swelled, and/or obstruct the device path and prevent the device from being inserted into the procedure sheath.Procedural factors and handling process may have contributed to the reported events.According to the instructions for use (ifu) ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ additionally, the ifu states ¿step 1: position balloon, insert the mynx control vcd into the procedural sheath through the sheath valve.Advance the catheter until the sheath catch nears the hub of the sheath.Rotate the sheath catch as needed to hook onto the side port of the procedural sheath.¿ the product analysis does not suggest that the issues experienced could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

Event Description

As reported, the sealant protection of a 6f/7f mynx control vascular closure device (vcd) was severely cracked, so the sealant first met the blood and reacted.Therefore, the product wasn¿t available and another unknown mynx control device was used and "recovered".There were no reports of patient injury.The mynx vcd was used in a used in transarterial chemoembolization (tace) procedure.There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Also, the mynx vcd was stored and prepped according to the ifu.The procedure used a retrograde approach.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 5mm in diameter.The puncture site did not have visible calcium/plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site, however the was little tortuosity of the vessel.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The device will be returned for evaluation.Addendum: product evaluation shows that the sealant sleeves were not fully covering the sealant.

• 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 karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 18288877
• MDR Text Key: 330011455
• Report Number: 3004939290-2023-03522
• 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: 12/07/2023

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 Expiration Date: 07/31/2024
• Device Catalogue Number: MX6760E
• Device Lot Number: F2219403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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: UNK VASCULAR SHEATH INTRODUCER