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 01/09/2019

Event Type  Injury  

Manufacturer Narrative

A lot history review was not possible as the lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the plug for a 6f-7f mynxgrip vascular closure device (vcd) was stuck on the sheath and was not delivered.Hemostasis was achieved by manual compression for an unknown amount of time.There were no patient complications or injuries.The devices were opened in a sterile field.The products were stored and handled as per instructions for use (ifu).There was nothing unusual noted about the device prior to opening the package or prior to use.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.Six out of the last seven mynxgrip in a row from this account have failed.Two separate doctors, and separate staff members noted this.

Manufacturer Narrative

As reported, the plug for a 6-7f mynxgrip vascular closure device (vcd) was stuck on the sheath and was not delivered.Hemostasis was achieved by manual compression for an unknown amount of time.There were no patient complications or injuries.The devices were opened in a sterile field.The products were stored and handled as per instructions for use (ifu).There was nothing unusual noted about the device prior to opening the package or prior to use.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.Six out of the last seven mynxgrip in a row from this account have failed.Two separate doctors, and separate staff members noted this.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 engaged to the black handle with stopcock open.The syringe was connected to the device.The advancer tube was returned separated from the device.The procedure sheath was observed on the outer cartridge tubing, fully retracted as received.The condition of the returned device likely indicates a complete removal of the device per mynxgrip instructions for use (ifu).It was reported that ¿the plug for a 6f-7f mynxgrip vascular closure device (vcd) was stuck on the sheath and was not delivered.¿ however, no sealant was observed stuck to the returned device components and/or returned with the device.It is unknown if the returned device was manipulated post the procedure.The catheter, shuttle cartridge and advancer tube were inspected for anomalies that may have contributed to the reported incident.No visual damages or anomalies were observed.The advancer tube was reinserted on to the device, and it was found properly engaged to the distal tamp lock as intended per the mynxgrip instructions for use (ifu).No anomalies were observed.A device history record (dhr) review of lot f1820603 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 through analysis of the returned device since the sealant was not received stuck to any component.Therefore, the exact cause of the issue reported could not be conclusively determined.Based on the limited information available for review, handling factors may have contributed to the sealant stuck to the shuttle/sheath since the device was received with no anomalies observed.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 dhr, 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.

• 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: 8318155
• MDR Text Key: 135493954
• Report Number: 3004939290-2019-01013
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F1820603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening