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

Catalog Number MX6721

Device Problem Defective Component (2292)

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

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while using a mynxgrip vascular closure device (vcd) proper hemostasis was not achieved after the device was removed from the patient's body.Hemostasis was achieved by manual compression for about 20 minutes.There was no reported patient injury.The patient recovered.The device was being used in a transfemoral cerebral angiography (tfca) procedure.The bleeding was noted immediately after sealant deployment/device removal.Fingertip compression was maintained on the skin during removal of the device.The mynxgrip vcd was stored, prepped, and used according to the instructions for use (ifu).There was no device damage noticed prior to opening the package.The deployer is mynx certified.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 5 mm in diameter.The stick location was the common femoral artery (cfa).There was mild vessel tortuosity.There was no presence of pvd or calcium in the vicinity of the puncture site.The target femoral site was not previously closed with any closure device prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the use of the mynx vcd.There was mild vessel tortuosity at the access site.There were no issues noted during balloon retraction (button #2 step).The complaint device is expected to be returned for evaluation.

Manufacturer Narrative

As reported, while using a mynxgrip vascular closure device (vcd), proper hemostasis was not achieved after the device was removed from the patient's body.Hemostasis was achieved by manual compression for about 20 minutes.There was no reported patient injury.The patient recovered.The device was being used in a transfemoral cerebral angiography (tfca) procedure.The bleeding was noted immediately after sealant deployment/device removal.Fingertip compression was maintained on the skin during removal of the device.The mynxgrip vcd was stored, prepped, and used according to the instructions for use (ifu).There was no device damage noticed prior to opening the package.The deployer is mynx certified.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 5 mm in diameter.The stick location was the common femoral artery (cfa).There was mild vessel tortuosity.There was no presence of peripheral vascular disease (pvd) or calcium in the vicinity of the puncture site.The target femoral site was not previously closed with any closure device prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the use of the mynx vcd.There was mild vessel tortuosity at the access site.There were no issues noted during balloon retraction (button #2 step).A non-sterile ¿mynxgrip vascular closure device 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that the shuttle was disengaged from the black handle, the syringe was connected to the device with stopcock closed.The sealant and advancer tube were not returned with the device.The condition of the returned device indicates a complete removal of the device.No visual damages or anomalies were observed.Since the condition of the returned device indicates a complete removal of the device, and the sealant/advancer tube were not returned, no functional test could be performed.However, per functional analysis, the balloon was inflated with water, and leak was found.Per microscopic analysis, visual inspection at high magnification showed a longitudinal tear in the balloon of the returned device.In addition, the slit presence in the outer cartridge was observed in the microscopic test.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 ¿sealant-failure to achieve hemostasis¿ was not confirmed since the sealant/advancer tube were not returned with the device and due to the nature of the complaint.However, an additional condition of ¿balloon-balloon loss of pressure¿ was noted in the returned device due to the longitudinal tear found.The exact cause of the issue experienced by the customer and the longitudinal tear could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is difficult determine what factors may have contributed to the failure to achieve hemostasis event reported since the device was returned in a condition that suggests the device was completely removed.However, patient factors, pharmacological factors and/or handling factors of the device are possible.Failing to achieve hemostasis immediately after vascular closure is a common procedural complication and are frequently related to stick technique, anticoagulation, blood pressure, adequate sheath removal technique, and proper placement of the sealant at the arteriotomy.Regarding the tear noted in the balloon of the returned device, access site vessel characteristics (although it was reported that there was no presence of pvd or calcium in the vicinity of the puncture site) and/or concomitant device factors most likely contributed to the reported event since this damage to the balloon is typically observed when it comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft).However, as this condition was not reported by the customer, it is unknown if this received condition occurred due to manipulations after the procedure.Yet, if this condition was present during use of the device, the damaged balloon could prevent proper placement of the sealant if proper tension (temporary hemostasis) was not applied.According to the product¿s ifu, which is not intended as a mitigation, ¿open the stopcock to deflate the balloon.To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing.Slowly withdraw the balloon catheter through the advancer tube lumen.Note: if unusual resistance is felt during balloon catheter withdrawal, pull the advancer tube and balloon catheter together through the tissue tract.While maintaining fingertip compression on the skin, remove the advancer tube from the tissue tract.Continue to apply fingertip compression for up to 1 minute or as needed.If hemostasis is not achieved, apply additional compression as necessary.¿ 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 failures noted could be related to the design or manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

A product history record (phr) review of lot f2232501 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.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): CORDIS 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: 17626147
• MDR Text Key: 322052036
• Report Number: 3004939290-2023-03326
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: F2232501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• 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: UNK 7F TERUMO SHEATH