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 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

A product history review is expected but not yet available.This device is available for analysis, but the engineering report is not yet available.However, it 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.Manual compression for less than 30 minutes was used for hemostasis.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The deployer is trained on use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was little presence of pvd / calcium in the vicinity of the puncture site.The balloon lost pressure while inside of the patient.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Manual compression for less than 30 minutes was used for hemostasis.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The device was used in a diagnostic procedure using a retrograde approach.The deployer was trained on use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was little presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.The balloon lost pressure while inside of the patient.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.A non-sterile 5f mynx control vascular closure device (vcd) involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the buttons 1 and 2 were not depressed, and the stopcock was found opened.The sealant was present as expected in its manufactured position fully covered per the sealant sleeves, which did not show any damage evidence or other type of anomaly.Additionally, the syringe was returned separated from the device along with the cordis catheter sheath introducer (csi) used.No additional anomalies were observed during this analysis.Functional testing was executed using a cordis lab syringe, and the non-functional condition of the balloon was confirmed as a leak was identified during balloon inflation.The leak was due to a rupture located on the balloon surface.Per microscopic analysis, a magnified visual analysis of the balloon surface was executed to identify the possible cause of the leak observed during the functional test, and the results showed a longitudinal rupture identified in the body of the balloon.The product history record (phr) review of lot f2227401 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal rupture found could not be conclusively determined during analysis.Based on the information available for review and product analysis, access site vessel characteristics (there was little presence of pvd/calcium in the vicinity of the puncture site) and/or concomitant device factors most likely contributed to the reported event since this type of damage is typically observed when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft).According to the 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: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, the ifu instructs users to discard the device if the balloon does not maintain pressure.Neither the phr review, nor the product analysis 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.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot f2227401 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• 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: 17799380
• MDR Text Key: 324047990
• Report Number: 3004939290-2023-03377
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000441
• UDI-Public: (01)10862028000441(17)241031(10)F2227401
• 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,Followup
• Report Date: 11/28/2023

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 Catalogue Number: MX5060E
• Device Lot Number: F2227401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/16/2023; 11/16/2023
• Supplement Dates FDA Received: 11/09/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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: 5F TERUMO SHEATH.