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

Catalog Number MX6760

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

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

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

As reported, the balloon of two 6f/7f mynx control vascular closure device (vcd) ruptured.The unknown sheath was switched for a new unknown sheath and a third unknown mynx control from a different box was used and the procedure completed.There was no reported patient injury.The initial mynx device was placed into the unknown working sheath all the way as the sheath hub was in the green hub of the device.Once the balloon was inflated and pulled back to the sheath, the balloon ruptured.The device was removed, and a second device was inserted the same way all the way into the sheath, balloon inflated and when pulled to the sheath, the balloon ruptured again.The device was removed.The physician then switched out the sheath for a new unknown sheath and a 3rd mynx control device was pulled from a different mynx control box and completed.A cordis 6f avanti sheath was used with the devices.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath or in distal end of the sheath after removal.The vessel diameter was verified to be greater than or equal to 5mm in diameter.The devices were opened in a sterile field.The devices were stored and prepped as per the instructions for use (ifu).The user is trained to the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices will not be returned for evaluation, they were disposed of.The reported events of ¿balloon-balloon loss of pressure¿ could not be confirmed as the devices were not received for analysis.The exact cause of the issues experienced could not be determined.Based on the information available for review, it is difficult to determine what factors may have contributed to the loss of pressure reported.However, access site vessel characteristics (although not reported) and/or concomitant device factors (although reported that there was no visible damage to the sheath noted) are likely since calcification at the access site and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon, and this occurred twice in the same puncture site.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 issues experienced are related to the design or manufacturing process of the units.Therefore, no corrective/preventative action will be taken at this time.

Event Description

As reported, the balloon of two 6/7f mynx control vascular closure device (vcd) ruptured.The unknown sheath was switched for a new unknown sheath and a third unknown mynx control from a different box was used and the procedure completed.There was no reported patient injury.The initial mynx device was placed into the unknown working sheath all the way as the sheath hub was in the green hub of the device.Once the balloon was inflated and pulled back to the sheath the balloon ruptured.The device was removed, and a second device was inserted the same way all the way into the sheath, balloon inflated and when pulled to the sheath balloon ruptured again.The device was removed.The physician then switched out the sheath for a new unknown sheath and a 3rd mynx control device was pulled from a different mynx control box and completed.A cordis 6f avanti sheath was used with the devices.There was no prior pta, stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath or in distal end of the sheath after removal.The vessel diameter was verified to be greater than or equal to 5mm in diameter.The devices were opened in a sterile field.The devices were stored and prepped as per the instructions for use (ifu).The user is trained to the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices will not be returned for evaluation, they were disposed of.

• 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: 19191607
• MDR Text Key: 341797224
• Report Number: 3004939290-2024-00208
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX6760
• Device Lot Number: F2314403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2023
• 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: 6F AVANTI 504606X; ANOTHER UNKNOWN MYNX CONTROL
• Patient Sex: Female
• Patient Weight: 64 KG