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

Catalog Number MX5060E

Device Problem Premature Activation (1484)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, while advancing the 5f mynx control vascular closure device (vcd) through a non-cordis sheath, the user encountered resistance.To address the issue, the user attempted retracting the delivery shaft slightly and then attempting to advance it again; however, resistance persisted.Eventually, the user decided to remove the device.There was no reported patient injury.Another mynx device was used for hemostasis and the patient recovered.The device was stored and prepared according to the instructions for use (ifu).The deployer was mynx certified.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 5 mm in diameter.There was mild vessel tortuosity.The stick location was reported to be the common femoral artery (cfa).There was no peripheral vascular disease (pvd)/calcium present in the vicinity of the puncture site.The target femoral site was not previously closed with any closure device prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the use of the mynx vcd.A non-cordis sheath was used and was not kinked/bent upon removal.There was no visible bent/damage in the distal end of the balloon shaft after removal.Excess force was not applied during insertion.A non-sterile mynx control vascular closure device 5f involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that buttons 1 and 2 were not depressed.The sealant, as expected, was in its manufactured position; nevertheless, the condition of the sealant showed a swelled state that resulted in the protrusion of the sealant at the distal portion of the sealant sleeves.The sealant sleeves showed no damage or anomaly and were fully covering the non-protruded portion of the sealant.Additionally, neither the syringe nor the catheter sheath introducer (csi) used in the procedure were returned for this analysis.A functional test for introduction/withdraw into the csi was attempted to simulate the use of the device; however, the sealant¿s swelled/protruded condition did not permit the full insertion into the cordis lab sample csi, confirming the impeded condition reported in the event.Due to the premature deployment condition observed in the device as received, a deployment test was executed by depressing both buttons (1 & 2), obtaining as a result the deployment of the sealant and the retraction of the deflated balloon.After the sealant was removed, the device was introduced into the csi to confirm that the obstruction was attributed directly to the swelled sealant blocking the path of the csi insertion.The device was introduced into the csi without any resistance or friction after the swelled sealant was removed.Per microscopic analysis, a high magnification visual analysis was performed to evaluate the sealant sleeves condition, and no damage or anomaly was observed in the received device.Nevertheless, the sealant protrusion was confirmed, resulting in a premature deployment condition.The reported event of ¿mynx control system-impeded¿ was confirmed through analysis of the returned device since the device was unable to be inserted into the lab sample csi during functional analysis due to the swelled condition of the sealant.Additionally, a condition was noted with the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant.The exact cause of the observed conditions 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 experienced.However, procedural/handling factors (although it was reported that excess force was not applied), and/or the condition of the sheath (which was not returned; although access site had mild tortuosity) possibly contributed to the impedance experienced during insertion, and premature swelling/exposure of the sealant.It should be noted that the mynx control device is manufactured with a slit at the end of the catheter cartridge tubing.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.The slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.As warned in the ifu, which is not intended as a mitigation, ¿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.¿ neither the product analysis, nor the information available for review suggest that the reported failures 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, while advancing the 5f mynx control vascular closure device (vcd) through a non-cordis sheath, the user encountered resistance.To address the issue, the user attempted retracting the delivery shaft slightly and then attempting to advance it again; however, resistance persisted.Eventually, the user decided to remove the device.There was no reported patient injury.Another mynx device was used for hemostasis and the patient recovered.The device was stored and prepared according to the instructions for use (ifu).The deployer is mynx certified.The femoral artery 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 5 mm in diameter.There was mild vessel tortuosity.The stick location was reported to be the common femoral artery (cfa).There was no pvd/calcium present in the vicinity of the puncture site.The target femoral site was not previously closed with any closure device prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the use of the mynx vcd.A non-cordis sheath was used and was not kinked/bent upon removal.There was no visible bent/damage in the distal end of the balloon shaft after removal.Excess force was not applied during insertion.The device was returned for evaluation.The product evaluation revealed that the sealant showed a swelled state that resulted in the protrusion of the sealant in the distal portion of the sealant sleeves.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18241012
• MDR Text Key: 329929834
• Report Number: 3004939290-2023-03510
• 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: 11/30/2023

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 Catalogue Number: MX5060E
• Device Lot Number: F2313004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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: UNKNOWN SHEATH