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 09/21/2023

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 a 6/7fr mynxgrip vascular closure device ruptured.Another unknown mynx device was used to achieve hemostasis.There was no reported patient injury.After inflating the balloon, the device was pulled back gently, and the device gave a jump.The tech then stopped and noticed there was "heme" coming back to the syringe.The user is trained to the device.A 6f 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.There was no presence of pvd / calcium in the vicinity of the puncture site.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.The device was opened in a sterile field.The device was prepped and stored per ifu (instructions for use).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will not be returned for evaluation, it was discarded.

Manufacturer Narrative

As reported, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) ruptured.Another unknown mynx device was used to achieve hemostasis.There was no reported patient injury.After inflating the balloon, the device was pulled back gently, and the device gave a jump.The tech then stopped and noticed there was "heme" coming back to the syringe.The user is trained to the device.A 6f non-cordis sheath was used.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 after removal.There was no presence of peripheral vascular disease (pvd) / calcium 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.The device was opened in a sterile field.The device was prepped and stored per the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will not be returned for evaluation, as it was discarded.The reported event of ¿balloon-balloon loss of pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the information available for review, is not possible to determine what factors may have contributed to the rupture reported.However, access site vessel characteristics (although it was reported that there was no the presence of pvd/calcium within the vicinity of the puncture site) and/or concomitant device factors (although it was reported that the sheath had no visible damages noted) are possible since calcification/pvd at the access site and/or a frayed/damaged sheath tip can cause damage to the balloon.According to the mynxgrip ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynxgrip 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 or venogram: common femoral artery or vein single wall puncture.Evidence of adequate flow.There is 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 provided, there is no indication 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: 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 17941327
• MDR Text Key: 326006875
• Report Number: 3004939290-2023-03429
• 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: 10/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: MX6721
• Device Lot Number: F2205502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: 6F TERUMO PINNACLE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White