MAUDE Adverse Event Report: CORDIS SANTA CLARA MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F; DEVICE, HEMOSTASIS, VASCULAR

Model Number MX6721

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

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.A review of the manufacturing documentation associated with this lot# f2006603 presented no issues during the manufacturing process that can be related to the reported complaint.

Event Description

As reported, the sealant of 67-7f mynxgrip vascular closure device (vcd) was not released properly.The mynx vascular closer device (vcd) was used in a percutaneous coronary procedure (pci).The part of it was left in the device.Hemostasis was achieved by manual compression.Manual compression was greater than 30 minutes.The patient recovered after the mynx event.There was no reported patient injury.The procedure used a retrograde approach.The deployer was mynx certified.The device was removed from the package as per the labeling instructions for use (ifu).The shuttle handle was not displaced.The sealant sleeve was not out of position.The sealant was not exposed during prep, while removing the device from package or during deployment.The stopcock of the introducer sheath was not opened prior to shuttle down.There was no significant resistance when shuttling down.No unusual force was applied when retracting the sheath.There were no kinks in the sheath or device after removal.The device storage temperature exceeded 25 °c.The femoral artery¿s suitability was verified on angiography or venography (mynxgrip only), including the insertion angle (30-45 degrees) of the vascular sheath introducer.Vessel type was arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was little vessel tortuosity.The stick location was normal puncture of common femoral artery (cfa).There was no presence of pvd / calcium in the vicinity of the puncture site.The device will be returned for analysis.Other procedural details were requested but were unavailable or unknown.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g4, g7, h1, h2, h3 and h6,h9,h10 as reported, the sealant of 6f/7f mynxgrip vascular closure device (vcd) was not released properly.The mynx vcd was used in a percutaneous coronary procedure (pci).The sealant was not released properly and part of it was left in the device.The part of it was left in the device.There was no reported patient injury.The procedure used a retrograde approach.The deployer was mynx certified.The device was removed from the package as per instructions for use (ifu).The shuttle handle was not displaced.The sealant sleeve was not out of position.The sealant was not exposed, during prep, while removing the device from the package or during deployment.The stopcock of the introducer sheath was not opened prior to shuttle down.There was no significant resistance when shuttling down.No unusual force was applied when retracting the sheath.There were no kinks in the sheath or device after removal.The device storage temperature exceeded 25 °c.The femoral artery¿s suitability was verified on angiography or venography (mynxgrip only), including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel type was arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was little vessel tortuosity.The stick location was of the common femoral artery (cfa).There was no presence of pvd / calcium in the vicinity of the puncture site.Hemostasis was achieved by manual compression and was greater than 30 minutes.The patient recovered after the mynx event.Other procedural details were requested but were unavailable or unknown.The product was returned for analysis.A non-sterile mynxgrip vascular closure device 6f/7f was returned.Per visual analysis, the shuttle was engaged to the black handle with the stopcock open, the sealant sleeve was displaced near the green shuttle hub, the advancer tube was deployed on the catheter shaft, and the sealant was observed to have been exposed to blood, covering the balloon¿s proximal tip as received.The condition of the returned device indicates an incomplete removal of the device.The syringe and procedural sheath were not returned with the device.The returned device was inspected for damages/anomalies that may have contributed to the reported incident.No visual damages or anomalies were observed.Per functional analysis, the advancer tube was proximally retracted and found properly engaged to proximal tamp lock as intended.A product history record (phr) review of lot f2006603 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿sealant stuck to device components¿ was confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as failure to remove the device, and storage temperatures exceeding 25 degrees may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, remove device, it instructs users to ensure complete balloon deflation, then slowly withdraw the balloon catheter through the advancer tube lumen.Failure to hold the advancer tube in place and/or a proper position of the tamping tube was not maintained during catheter removal, the sealant could be dislodged from the vessel wall, resulting in the reported incident.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.

• Brand Name: MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 10197079
• MDR Text Key: 196940153
• Report Number: 3004939290-2020-01803
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)220331(10)F2006603
• Combination Product (y/n): N
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F2006603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1