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 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use of a 6f-7f mynxgrip vascular closure device, the sealant was stuck on the device.There was no patient injury and the device will be returned for analysis.

Manufacturer Narrative

During use of a 6f-7f mynxgrip vascular closure device (vcd), the sealant was stuck on the device.There was no patient injury.Multiple attempts to obtain additional information were made without success.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 procedural sheath was not returned with the device.The sealant was stuck to the catheter near the slit of shuttle cartridge.It is unknown whether the condition / orientation of the device was due to user manipulation or subsequent handling.The catheter and shuttle cartridge were inspected for anomalies that may have obstructed the device path during deployment.No anomalies were observed.Leak testing was performed on the balloon per mynxgrip instructions for use (ifu).The balloon was fully inflated and pressure was held with proper functioning of the inflation indicator.The advancer tube was properly engaged to tamp lock during the investigation.The product history record (phr) review of lot f1715901 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 through analysis of the returned device since it was received with the sealant stuck to the catheter near the slit of shuttle cartridge.However, the exact cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the limited information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced.However, handling factors may have contributed to the sealant becoming stuck to the catheter/shuttle since there were no anomalies noted that may have obstructed the device path during deployment.It should be noted that if the shuttle is not advanced until the advancer tube is engaged to the proximal tamp lock, this will cause the advancer tube and sealant to follow the shuttle cartridge back out of the tissue tract during the retraction step, resulting in the sealant backing out during shuttle/sheath retraction step.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, ¿while maintaining light tension to keep the balloon abutted against the arteriotomy or venotomy, immediately grasp the advancer tube at the skin and gently advance until the single marker is fully visible and then hold in place for up to 30 seconds.¿ neither the phr, nor the product analysis or information available for review suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

The device was returned and section d10 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

During use of a 6f-7f mynxgrip vascular closure device (vcd), the sealant was stuck on the device.There was no patient injury.Multiple attempts to obtain additional information were made without success.The product was not returned for analysis.A product history record (phr) review of lot f1715901 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¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue reported could not be determined.Based on the limited information available for review, handling factors during device removal may have contributed to the sealant stuck to the advancer tube after removal.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, step 3: 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, part of the sealant could be dislodged, resulting in the reported incident.Neither the phr, nor the information available for review suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action 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: 8424156
• MDR Text Key: 138899120
• Report Number: 3004939290-2019-01099
• Device Sequence Number: 1
• Product Code: MGB
• 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,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F1715901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1