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 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

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 6/7f mynx grip vascular closure device (vcd) ruptured during patient use.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The vcd was used with a 6f 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 no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.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 be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3 and h6.The balloon of a 6/7f mynx grip vascular closure device (vcd) ruptured during patient use.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The vcd was used with a 6f 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 no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.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 product was returned for analysis.A non-sterile mynxgrip vascular closure device 6f/7f was returned for investigation inside a clear plastic bag.Per visual analysis the shuttle was disengaged to the black handle.The syringe was received attached with the device and the stopcock was found open.The sealant and advancer tube remained in the manufacturing position.The procedure sheath was not returned.In addition, the balloon was received fully deflated.Per functional analysis an inflation/deflation test was performed which revealed a leak in the balloon of the returned device.Per microscopic analysis a longitudinal tear in the balloon was revealed.The reported ¿balloon loss of pressure¿ was confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.This type of tear 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).Vessel characteristics may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation of risk, users are instructed not to use the device if the balloon does not maintain pressure.Neither the event description nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no 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 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: 18169821
• MDR Text Key: 328535050
• Report Number: 3004939290-2023-03497
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: F2234602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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 SHEATH