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 11/15/2023

Event Type  malfunction  

Event Description

As reported, the balloon on a 6/7f mynx grip vascular closure device (vcd) popped upon pullback.Hemostasis was achieved with manual pressure.There were no reports of patient injury.The device was used in an interventional procedure.The procedure used a retrograde approach.The deployer was mynx certified.A 6f 11cm cordis avanti+ sheath introducer was used.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.The vessel was moderately tortuous and there was moderate presence of pvd/ calcium in the vicinity of the puncture site.The mynx vcd was stored and prepped according to the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery or vein.There was no visible damage to the distal end of the sheath after removal.The device will not be returned for evaluation because the infection status of the patient cannot be confirmed.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon on a 6/7f mynx grip vascular closure device (vcd) popped upon pullback.Hemostasis was achieved with manual pressure.There were no reports of patient injury.The device was used in an interventional procedure.The procedure used a retrograde approach.The deployer was mynx certified.A 6f 11cm cordis avanti+ sheath introducer was used.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.The vessel was moderately tortuous and there was moderate presence of pvd/calcium in the vicinity of the puncture site.The mynx vcd was stored and prepped according to the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery or vein.There was no visible damage to the distal end of the sheath after removal.The device was not returned for evaluation as the infection status of the patient cannot be confirmed.The reported ¿balloon loss of pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause of the loss of pressure reported could not be determined.Based on the information available for review, access site vessel characteristics (presence of pvd/calcium in the vicinity of the puncture site with moderate tortuosity) most likely contributed to the loss of pressure reported since calcification/pvd at the access site can cause damage to the balloon, resulting in a loss of pressure.According to the mynxgrip ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynxgrip 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 or venogram: common femoral artery or vein 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 provided, there is no indication the event is related to the device design or manufacturing process.Therefore, no preventative or corrective 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, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18257545
• MDR Text Key: 329618179
• Report Number: 3004939290-2023-03515
• 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: 12/04/2023

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: MX6721
• Device Lot Number: F2328302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• 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: N/A.