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

Model Number N/A

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

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

Event Date 03/18/2024

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 6/7f mynx control vascular closure device (vcd) ruptured and couldn't be used.Hemostasis was achieved with manual compression for twenty-five minutes, resulting in no extended hospitalization.There was no reported patient injury.The device was used during a transarterial chemo-embolization (tace) using a retrograde approach, and the physician was being trained on its use.A 6f non cordis sheath was used.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use.The vessel type was femoral arterial, and its diameter was verified to be greater than 5 mm.There was severe vessel tortuosity and severe presence of pvd / calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was prepped according to the instructions for use (ifu).The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) ruptured and couldn't be used.Hemostasis was achieved with manual compression for twenty-five minutes, resulting in no extended hospitalization.There was no reported patient injury.The device was used during a transarterial chemoembolization (tace) using a retrograde approach, and the physician was being trained on its use.A 6f non-cordis sheath was used.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use (ifu).The vessel type was femoral arterial, and its diameter was verified to be greater than 5mm.There was severe vessel tortuosity and severe presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.The mynx vcd was prepped according to the ifu.A non-sterile ¿mynx control vcd 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe was received separated from the device, and the procedural sheath was not received for evaluation.The stopcock was observed in the open position, and the balloon was found fully deflated.In addition, the sealant was found in its manufactured position, fully covered by the sealant sleeves and not exposed to blood.Also, no damages were observed to sealant sleeves assembly.Per functional analysis, an inflation/deflation test was conducted as per the mynx control ifu.The findings indicated a leak in the balloon of the returned device.Per microscopic analysis, a longitudinal tear was discovered in the balloon of the returned device upon visual inspection at high magnification.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear found could not be conclusively determined during analysis.Based on the information available for review and product analysis, access site vessel characteristics (there was severe vessel tortuosity and severe presence of pvd / calcium in the vicinity of the puncture site) and/or concomitant device factors (which was not returned) most likely contributed to the reported event since a calcified vessel and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause this type of damage to the balloon.According to the ifu, which is not intended as a mitigation, the ifu instructs ¿confirm via femoral arteriogram: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, the ifu reports that the safety and effectiveness of the mynx control vcd have not been established in patients with clinically significant peripheral vascular disease in the vicinity of the puncture.Additionally, users are instructed to discard the device if the balloon does not maintain pressure.Neither the product analysis, nor the information available for review suggest that the reported failure 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: 19080872
• MDR Text Key: 340117190
• Report Number: 3004939290-2024-00169
• 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: 04/10/2024

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: MX6760E
• Device Lot Number: F2322703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• 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: TERUMO 6F RADIFOCUS 2 INTRODUCER
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian