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

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Complete udi# (b)(4).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

As reported, the sealant of a 6f/7f mynxgrip vascular closure device (vcd) was not going down and was stuck in the advancer tube.In addition, there was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

The device was returned and section d9 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the sealant of a 6f/7f mynxgrip vascular closure device (vcd) was not going down and was stuck in the advancer tube.There was no reported patient injury.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 procedure sheath was on the catheter shaft, and the sealant and advancer tube were observed to have remained in the manufacturing position as received.It was noted that the sealant grip tip was exposed to moisture and adhered to the device components as received.The condition of the retuned device is consistent with the reported incident.Per functional analysis, the sealant was displaced from the device components.The shuttle down procedure was simulated on the returned device, and the advancer tube was found properly engaged to the proximal tamp lock as intended per the mynxgrip instructions for use (ifu).The procedural sheath, catheter and shuttle cartridge were inspected for anomalies that may have obstructed the device path during the procedure.No anomalies were observed.Per microscopic analysis, the sealant was exposed to moisture and stuck/adhered to the device components as received.The condition of the returned device indicates that the sealant may have been prematurely hydrated, and during shuttling and unsheathing step, the sealant hindered/obstructed the device path from being advanced, which may have contributed to the reported incident.A product history record (phr) review of lot f1807301 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 the sealant becoming prematurely hydrated, may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, it states to insert the mynxgrip into the procedural sheath up to the white shaft marker, then inflate the balloon until the black marker is fully visible on the inflation indicator.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/preventative 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: 11020128
• MDR Text Key: 223619182
• Report Number: 3004939290-2020-01995
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)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,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: MX6721
• Device Lot Number: F1807301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1