MAUDE Adverse Event Report: CORDIS 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 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, while advancing the 6/7f 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.The device was removed.Another mynx device was used to achieve hemostasis and the patient recovered.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).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 5mm in diameter.There was no calcification, and the access vessel tortuosity was mild.The stick location was the common femoral artery (cfa).There was no pvd/calcium in the vicinity of the puncture site; the target femoral site was not previously closed with any closure device prior to this procedure and there was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the use of the mynx vcd.The non-cordis sheath used was not kinked/bent upon removal.There was no visible bent/damage in the distal end of the balloon shaft after removal.No excess force was applied during insertion.The deployer is mynx certified.The device was returned for evaluation.Visual analysis: a non-sterile ¿mynx control vcd 6f/7f¿ involved in the reported complaint was returned for investigation inside a clear plastic bag.Visual inspection of the received device showed that both button 1 and button 2 were not depressed.The syringe and the procedure sheath were not received for evaluation and the stopcock was observed closed.The balloon was found fully deflated, and the sealant was found partially exposed from the sealant sleeves.It was observed to have been slightly kinked/bent as received, no residues of blood were noted on the sealant.Functional analysis: without the return of the procedure sheath, a physical evaluation to determine whether there was damage to the procedural sheath could not be made.An applicable lab introducer sheath was used to perform the insertion/withdrawal test on the returned product, and the device was able to be inserted/advanced through the lab introducer sheath without issue.The returned device performed as intended per the mynx control instructions for use (ifu).Additionally, a simulated deployment test was performed on the returned device.Button 1 was able to be depressed to deploy the sealant with no resistance felt.No issues were noted with respect to button 1 deployment during the investigation.The returned device performed as intended, button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Microscopic analysis: visual inspection at high magnification showed that the sealant was found partially exposed from the sealant sleeves as the sleeves were observed to be slightly kinked/bent as received, no residues of blood were noted on the sealant.The reported ¿mynx control system-impeded¿ was not confirmed as the device passed insertion/withdrawal testing with the lab sample sheath, unfortunately the concomitant device was not returned for analysis.However, the reported ¿mynx control system- deployment difficulty-premature¿ was confirmed as the sealant was found partially exposed and the sealant sleeves were slightly kinked/bent.It is likely prepping and/or handling factors may have contributed to the issue reported as the sealant was returned exposed.If the outer sleeve is damaged during prepping phase and/or insertion into sheath, that could cause the sealant to be exposed prematurely and/or obstruct the device path and prevent the device from being inserted into the procedural sheath.As warned in the instructions for use (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.¿ based on the analysis provided it does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, while advancing the 6/7f 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.The device was removed.Another mynx device was used to achieve hemostasis and the patient recovered.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).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 no calcification, and the access vessel tortuosity was mild.The stick location was the common femoral artery (cfa).There was no pvd / calcium in the vicinity of the puncture site; the target femoral site was not previously closed with any closure device prior to this procedure and there was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the use of the mynx vcd.The non-cordis sheath used was not kinked/bent upon removal.There was no visible bent/damage in the distal end of the balloon shaft after removal.No excess force was applied during insertion.The deployer is mynx certified.The device was returned for evaluation and the sealant was found partially exposed from the sealant sleeves and it was observed to have been slightly kinked/bent as received.

• 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: 18374195
• MDR Text Key: 331373641
• Report Number: 3004939290-2023-03545
• 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: 12/21/2023

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: 02/28/2024
• Device Catalogue Number: MX6760E
• Device Lot Number: F2222206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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: 6F TERUMO SHEATH