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

Catalog Number MX6721

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

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of two 6/7f mynxgrip vascular closure devices (vcd) ruptured.A third mynxgrip was used, and the procedure was completed.There was no reported patient injury.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.There was no visible damage to the sheath or in the distal end of the sheath after removal.There was no presence of pvd in the vicinity of the puncture site.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was no vessel tortuosity.There was no calcium present at the site of the unknown sheath.The user is trained to the device.The device was opened in a sterile field.The device was stored and prepped according to instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices will be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of two 6f/7f mynxgrip vascular closure devices (vcd) ruptured.A third mynxgrip was used, and the procedure was completed.There was no reported patient injury.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.There was no visible damage to the sheath or in the distal end of the sheath after removal.There was no presence of peripheral vascular disease (pvd) in the vicinity of the puncture site.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was no vessel tortuosity.There was no calcium present at the site of the unknown sheath.The user was trained to the device.The device was opened in a sterile field.The device was stored and prepped according to instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was returned, however not received for evaluation.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 it was reported that there was no calcium present at the site of the unknown sheath.) 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.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.

• Brand Name: MYNXGRIP
• 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: 18914766
• MDR Text Key: 337791936
• Report Number: 3004939290-2024-00115
• 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,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX6721
• Device Lot Number: F2331702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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: UNKNOWN MYNXGRIP; UNKNOWN SHEATH
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White