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

Catalog Number MX6721

Device Problems Decrease in Pressure (1490); Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 10/27/2023

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.Additional information is pending.

Event Description

As reported, the balloon of a 6/7f mynxgrip vascular closure device (vcd) ruptured at the second stop during patient use.The mynx deployed but slowly deflated before 90 sec flat could be achieved.Hemostasis was achieved by manual pressure for less than thirty minutes.There was no reported patient injury.The mynx vcd was prepped according to instructions for use (ifu).During the 90 sec flat the balloon completely deflated and manual pressure was held.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.There was no visible damage in the distal end of the sheath after removal.A 6f 11 cm cordis brite tip sheath was used.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 6f cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.The mynx vcd was used in interventional procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) ruptured at the second stop during patient use.The mynx deployed but slowly deflated before 90 sec flat could be achieved.Hemostasis was achieved by manual pressure for less than thirty minutes.There was no reported patient injury.The mynx vcd was prepped according to instructions for use (ifu).During the 90 sec flat, the balloon completely deflated and manual pressure was held.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.There was no visible damage in the distal end of the sheath after removal.A 6f 11 cm cordis brite tip sheath was used.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 6f cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.The mynx vcd was used in an interventional procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynxgrip vascular closure device 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the shuttle was engaged to the black handle.The syringe was received attached to the device and the stopcock was found opened.The sealant and advancer tube remained in their manufactured positions.A cordis procedure sheath was returned separately, no damages were observed on it.In addition, the balloon was received fully deflated.Per functional analysis, an inflation/deflation test was performed on the balloon of the returned device.The results revealed a leak in the balloon of the returned device.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear found could not be conclusively determined during analysis.Based on the information available for review and product analysis, access site vessel characteristics (ruptured at the second stop) most likely contributed to the reported event since 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).According to the instructions for use (ifu), which is not intended as a mitigation, ¿the safety and effectiveness of 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, the ifu instructs users to discard the device if the balloon does not maintain pressure.Neither the product analysis, nor the information available for review suggest 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 ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 18122269
• MDR Text Key: 329246485
• Report Number: 3004939290-2023-03486
• 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: 01/08/2024

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: F2320903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• 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 11 CM CORDIS BRITE TIP SHEATH