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

Model Number N/A

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Udi # is (b)(4).The device was not returned for analysis.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.The device is available but was not yet returned for analysis.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.This is one of 5 devices associated with the reported event but the manufacturing report numbers are not available.The related numbers are 3004939290-2019-01041 and 3004939290-2019-01042, 3004939290-2019-01043, 3004939290-2019-01044.

Event Description

The 6f-7f mynxgrip balloon did not feel as if it fully deflated after deployment and the user felt resistance upon pulling it out.Hemostasis took longer than expected to achieve.There was no patient injury and the device will be returned for analysis.This is one of 5 events from the same facility involving the same lot number.The users were trained and were very experienced operators at this lab.All had the same complaint.The device was opened in a sterile filed and were used in the patient.The product was also stored according to the labeling.Additional details were requested but were not available.

Manufacturer Narrative

The 6f-7f mynxgrip vascular closure device (vcd) balloon did not feel as if it fully deflated after deployment and the user felt resistance upon pulling it out.Hemostasis took longer than expected to achieve.There was no patient injury.The user was trained and a very experienced operator at this lab.The device was opened in a sterile filed and were used in the patient.The product was also stored according to the labeling.Additional details were requested but were not available.The device was not returned for analysis.A product history record (phr) review of lot f1831202 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon failure to deflate¿ could not be confirmed as the device was not returned for analysis.The exact cause of the failure to deflate experienced could not be determined.Based on the limited information available for review, it is not possible to determine what may have contributed to the failure to deflate reported.It¿s possible that the issue could be due to use of a viscous contrast solution, or a high contrast to saline ratio solution to inflate the balloon.The mynxgrip¿s instructions for use (ifu), which is not intended as a mitigation, instructs users to fill the syringe with 2 to 3 ml of sterile saline, and to inflation the balloon with the solution.It also states that the balloon may be prepped with a diluted contrast solution (50% contrast / 50% saline), in place of 100% saline, in order to visualize the balloon while pulling back to the arteriotomy, and to ensure that the balloon properly abuts the arteriotomy.It should be noted that viscous contrast solution might cause a difficulty to inflate/deflate balloon and/or delay the balloon¿s inflation/deflation time.Neither the phr, nor the information available for review suggests a design or manufacturing related cause for the reported events.Therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

The 6f-7f mynxgrip vascular closure device (vcd) balloon did not feel as if it fully deflated after deployment and the user felt resistance upon pulling it out.Hemostasis took longer than expected to achieve.There was no patient injury.The user was trained and a very experienced operator at this lab.The device was opened in a sterile filed and were used in the patient.The product was also stored according to the labeling.Additional details were requested but were not available.The non-sterile mynxgrip vascular closure device 6f/7f involved in the reported complaint was not returned; therefore, a physical investigation could not be performed.However, 6 sterile unused mynxgrip devices from the same lot f1831202 were received for evaluation in the original sealed packages.Three samples were randomly chosen for visual inspection and no anomalies were observed.Balloon inflation and deflation testing was performed on the balloons of the sterile unused devices per the mynxgrip instructions for use (ifu).The balloons were fully inflated with water and pressure was maintained with proper functioning of the inflation indicator.The balloon deflated as intended during test.All three devices passed the test and are deemed to meet specifications.A product history record (phr) review of lot f1831202 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon failure to deflate¿ could not be confirmed as the device was not returned for analysis.Additionally, there were no anomalies noted to the sterile devices reviewed.The exact cause of the failure to deflate experienced by the customer could not be determined.Based on the limited information available for review, it is not possible to determine what may have contributed to the failure to deflate reported.It¿s possible that the issue could be due to use of a viscous contrast solution, or a high contrast to saline ratio solution to inflate the balloon.The mynxgrip¿s instructions for use (ifu), which is not intended as a mitigation, instructs users to fill the syringe with 2 to 3 ml of sterile saline, and to inflation the balloon with the solution.It also states that the balloon may be prepped with a diluted contrast solution (50% contrast / 50% saline), in place of 100% saline, in order to visualize the balloon while pulling back to the arteriotomy, and to ensure that the balloon properly abuts the arteriotomy.It should be noted that viscous contrast solution might cause a difficulty to inflate/deflate balloon and/or delay the balloon¿s inflation/deflation time.Neither the phr, the analysis of the sterile devices, 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: 8351559
• MDR Text Key: 136593188
• Report Number: 3004939290-2019-01045
• Device Sequence Number: 1
• Product Code: MDB
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: MX6721
• Device Lot Number: F1831202
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/14/2019; 04/15/2019
• Supplement Dates FDA Received: 03/15/2019; 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization