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 08/24/2023

Event Type  malfunction  

Event Description

As reported, a 6f/7f mynx control vascular closure device (vcd) was unable pass through an unknown catheter sheath introducer (csi) as there was strong resistance experienced.As a result, the device could not be used, and hemostasis was achieved via 20 minutes of manual compression.There were no reported injuries to the patient.It was reported that the unknown csi was not kinked during the attempted insertion of the mynx control vcd, and excess force was applied during the attempted insertion of the mynx control vcd.This was during a carotid artery stenting (cas) procedure in which a retrograde approach was used.The device was prepped according to the instructions for use (ifu) and there was no damage to the device or device packaging prior to use.The femoral artery¿s suitability was verified on angiography, including a csi insertion angle of 30-34 degrees, and a vessel diameter greater than 5mm.The puncture site did not have visible calcium, plaque, or stenoses greater than 50 percent.There was no stent near the puncture site, and the site was not previously closed with less than 30 days prior to this procedure.The patient¿s body mass index (bmi) was not greater than 40kg/m2.Additionally, there was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to using the mynx control vcd.The device will be returned for evaluation.Addendum: product evaluation revealed that the sealant was prematurely exposed.

Manufacturer Narrative

Complaint conclusion: a 6f/7f mynx control vascular closure device (vcd) was unable pass through an unknown catheter sheath introducer (csi) as there was strong resistance experienced.As a result, the device could not be used, and hemostasis was achieved via 20 minutes of manual compression.There were no reported injuries to the patient.It was reported that the unknown csi was not kinked during the attempted insertion of the mynx control vcd, and excess force was applied during the attempted insertion of the mynx control vcd.This was during a carotid artery stenting (cas) procedure in which a retrograde approach was used.The device was prepped according to the instructions for use (ifu) and there was no damage to the device or device packaging prior to use.The femoral artery¿s suitability was verified on angiography, including a csi insertion angle of 30-34 degrees, and a vessel diameter greater than 5mm.The puncture site did not have visible calcium, plaque, or stenoses greater than 50 percent.There was no stent near the puncture site, and the site was not previously closed with less than 30 days prior to this procedure.The patient¿s body mass index (bmi) was not greater than 40kg/m2.Additionally, there was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to using the mynx control vcd.The product was returned for analysis.A non-sterile mynx control vcd 6f/7f(ce mark) was returned inside of clear plastic bag for investigation.Per visual analysis both button 1 and button 2 were not depressed.Neither the procedure sheath nor the syringe was retuned for analysis.The stopcock is set on the open position.The sealant is moved toward the proximal area of the catheter approximately one (1) cm from the balloon.The sealant is saturated in blood and exposed due to the sleeves present a severe kinked condition.The atraumatic tip does not present any damages or anomalies.No other anomalies were noted.Per dimensional analysis the slit length was not verified due to the observed kink.The catheter usable length was found within specification.The actual measure was 152 mm.Per functional analysis simulated insertion/withdrawal into a lab sample csi was not possible due to severe kinking of sleeves.Simulated deployment test was performed on the returned device.The tension indicator was aligned manually.Buttons 1 and button 2 were able to be depressed to deploy the sealant and withdraw the balloon with no resistance felt.No issues were noted with respect to both buttons 1 and 2 deployment during the device failure investigation.The returned device performed as intended per the mynx control ifu.Per microscopic analysis the kinked condition and the exposing of the sealant was confirmed.The reported ¿mynx control system impeded¿ and¿ mynx control system deployment difficulty- premature¿ were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural/handling factors may have contributed to the event as evidenced by the severe kinking noted on the sleeves during analysis.According to the safety information in the instructions for use, ¿warnings do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.The product analysis does not suggest that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action 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, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18245480
• MDR Text Key: 330459760
• Report Number: 3004939290-2023-03512
• 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
• Type of Report: Initial
• Report Date: 12/01/2023

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 Catalogue Number: MX6760E
• Device Lot Number: F2227803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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.