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 08/28/2023

Event Type  malfunction  

Event Description

As reported, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) ruptured during the procedure while inside of the patient.A second mynx device was used to achieve hemostasis.There were no reported injuries to the patient.This was during an interventional procedure in which a retrograde approach was made with a 7f non-cordis catheter sheath introducer (csi).The device was stored and prepped per the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography, including a csi insertion angle of 30 ¿ 45 degrees and a vessel diameter greater than or equal to 5mm.There was mild tortuosity at the access site; however, there were no signs of calcium.There was no damage to the distal end of the csi after its removal.The device will be returned for evaluation.

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 and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) ruptured during the procedure while inside of the patient.A second mynx device was used to achieve hemostasis.There were no reported injuries to the patient.This was during an interventional procedure in which a retrograde approach was made with a 7f non-cordis catheter sheath introducer (csi).The device was stored and prepped per the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography, including a csi insertion angle of 30 ¿ 45 degrees and a vessel diameter greater than or equal to 5mm.There was mild tortuosity at the access site; however, there were no signs of calcium.There was no damage to the distal end of the csi after its removal.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 separated from the device, and the stopcock was found opened.The sealant and advancer tube remained in their manufactured positions.The procedural sheath was not returned with the device.In addition, the balloon was found fully deflated.Per functional analysis, leak testing was performed on the balloon of the returned device per the mynxgrip ifu.The results revealed a leak in the balloon.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.The product history record (phr) review of lot f2232501 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.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 (although it was reported that there was no sign of calcium) and/or concomitant device factors (although reported there was no visible damage noted to the distal end of the csi and it was not returned) most likely contributed to the reported event since this damages to the balloon are 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 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 phr review, nor the product analysis 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, g6, h1, h2, h3, h6, and h10.A review of the manufacturing documentation associated with lot f2232501 presented no issues during the manufacturing process that can be related to the reported event.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 and will be submitted within 30 days upon receipt.

• 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: 17807824
• MDR Text Key: 324163837
• Report Number: 3004939290-2023-03385
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)241130(10)F2232501
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2023

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 Catalogue Number: MX6721
• Device Lot Number: F2232501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: Not provided; 11/16/2023
• Supplement Dates FDA Received: 11/10/2023; 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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: MYNX VCD.