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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record (dhr) associated with lot#: f1802302 revealed no anomalies during the manufacturing, and inspection processes that can be associated with the reported event.Additional information is pending, and will be sent in upon 30 days after receipt.

Event Description

The seal of a 6f/7f mynxgrip vascular closure device (vcd) was not going down from the advancer tube.There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been update accordingly.The seal of a 6f/7f mynxgrip vascular closure device (vcd) was not going down from the advancer tube.There was no reported patient injury.Additional procedural details were requested but are unknown.The product was returned for analysis.A non-sterile mynxgrip vascular closure device 6f/7f involved in the reported complaint was returned for investigation.Per visual analysis, the shuttle was engaged to the black handle, the syringe was connected to the device with the stopcock open, the procedural sheath was on the catheter, fully retracted, 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 device was returned in the condition of an incomplete removal of 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 per the mynxgrip instructions for use (ifu).No functional non-conformities were observed on the returned device.A product history record (phr) review of lot f1802302 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 not confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.The reported event may have been attributed to incorrectly following the instructions for use (ifu).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 event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• 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: 11046639
• MDR Text Key: 223202661
• Report Number: 3004939290-2020-02013
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F1802302
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1