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

Catalog Number MX5060E

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 11/06/2023

Event Type  malfunction  

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.

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.The balloon ruptured during patient use.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.A 5f non-cordis sheath was used.There was no prior pta, stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath after removal.There was no visible damage in distal end of the sheath after removal.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was little vessel tortuosity.The user was trained to the device.The device was opened in a sterile field.The device was stored and prepared in accordance with the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3 and h6.As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.The balloon ruptured during patient use.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.A 5f non-cordis sheath was used.There was no prior pta, stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath after removal.There was no visible damage in distal end of the sheath after removal.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was little vessel tortuosity.The user was trained to the device.The device was opened in a sterile field.The device was stored and prepared in accordance with the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The product was not returned for analysis.The reported ¿balloon loss of pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause of the loss of pressure reported could not be determined.Based on the information available for review, access site vessel characteristics most likely contributed to the loss of pressure reported as tortuosity at the access site can cause damage to the balloon, resulting in a loss of pressure.According to the mynx control ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram prior to using the mynx control vcd: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Based on the information available for review, there is no indication that the event is related to the design or manufacturing process of the unit.Therefore, no corrective or preventative 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 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
• MDR Report Key: 18256402
• MDR Text Key: 329605098
• Report Number: 3004939290-2023-03514
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: F2311702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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