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

Model Number N/A

Device Problem Premature Activation (1484)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

As reported, the sealant protection sleeve of a 5f mynx control vascular closure device (vcd) was damaged and could not enter the non cordis sheath.The sealant sleeve was split and the sealant was exposed.The procedure was completed using another unknown mynx device.There was no reported patient injury.The device was attempted to be used for hemostasis in a percutaneous transluminal angioplasty (pta) procedure.The user was mynx certified.A 5f non cordis sheath was used.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.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: complaint conclusion: as reported, the sealant protection sleeve of a 5f mynx control vascular closure device (vcd) was damaged and could not enter the non-cordis sheath.The sealant sleeve was split and the sealant was exposed.The procedure was completed using another unknown mynx device.There was no reported patient injury.The device was attempted to be used for hemostasis in a percutaneous transluminal angioplasty (pta) procedure.The user was mynx certified.A 5f non-cordis sheath was used.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.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 approximately 1/3 of its total travel and button 2 was not depressed.The syringe was received connected to the device, and the stopcock was observed closed.In addition, the balloon was found fully deflated.The sealant was observed on the device, covering the balloon neck as received and exposed to blood.The sealant sleeves were observed to have been severely kinked/bent.In addition, an unknown procedural sheath was locked onto the sheath catch and blood was noted in the procedural sheath, no damages were observed on it.The device was inspected for damages/anomalies that may have contributed to the reported failure and no frayed/split/torn conditions were observed on the returned device.A dimensional test was not performed on the returned device due to the severely kinked/bent condition observed to the sealant outer sleeve assembly.Per functional analysis, the sealant was removed from the device component.Button #1 was able to be fully depressed and locked in place with no resistance felt during the device failure investigation.No issues were noted with respect to button 1 during the investigation.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Per microscopic analysis, visual inspection at high magnification revealed that the sealant sleeves were observed to have been severely kinked/bent.The device was inspected for damages/anomalies that may have contributed to the reported failure and no frayed/split/torn conditions were observed on the returned device.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severely kinked/bent condition of the sleeves was noted.Additionally, the reported event of ¿mynx control system-deployment difficulty-premature¿ could not be confirmed as the device was received with button #1 partially depressed; therefore, initiating the deployment of the 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 (such as using excessive force during insertion into the sheath) possibly contributed to the damaged condition of the sealant sleeves, and the swelling 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 assembly is assembled with 2 side slit overlapping outer sleeves.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.If the outer sleeve is damaged/kinked during prepping phase and/or insertion into sheath, it could cause the sealant to be exposed/swollen prematurely and/or obstruct the device path and prevent the device from being inserted into the procedural sheath.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 failures 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: 18685418
• MDR Text Key: 336106657
• Report Number: 3004939290-2024-00071
• 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: 04/23/2024

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 Model Number: N/A
• Device Catalogue Number: MX5060E
• Device Lot Number: F2324903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• 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: 5F TERUMO SHEATH; UNKNOWN MYNX
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian