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

Model Number MX6721

Device Problems Decrease in Pressure (1490); Material Puncture/Hole (1504); Material Rupture (1546); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 6f-7f mynxgrip vascular closure device (vcd) failed to achieve hemostasis.There was no reported patient injury.

Manufacturer Narrative

The device was received on 09/24/2018.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the 6f-7f mynxgrip vascular closure device (vcd) failed to achieve hemostasis.There was no reported patient injury.No additional information is available.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 cartridge was disengaged from the black handle.A tear was found on the balloon.The sealant remained inside the shuttle cartridge.The condition of the returned device indicates a balloon loss of pressure which resulted in the sealant not being deployed.Visual inspection at high magnification confirmed a radial tear in the balloon, approximately 4 mm from the balloon proximal neck.The distal segment of the balloon did not separate from the device and remained attached to the catheter.A device history record (dhr) review of lot f1733101 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿failure to achieve hemostasis was not confirmed through analysis of the returned device since the sealant was still inside the shuttle cartridge.The condition of the returned device did not match the description provided.However, a tear was found on the balloon, which indicates that a balloon loss of pressure occurred during use.The exact cause of the tear could not be determined during analysis.Based on the limited information available for review and the product analysis, access site vessel characteristics (although not reported) or sheath tip condition factors (although not returned) may have contributed to the tear found since a calcified vessel and/or a frayed sheath tip may cause damage to the balloon.This type of tear is typically observed when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft), potentially contributing to a tear in the balloon.It is possible that this balloon tear led the customer to remove the device from the patient without deployment, and therefore reported it as failing to achieve hemostasis.According to the instructions for use, which is not intended as a mitigation, users are instructed to discard the device if the balloon does not maintain pressure.Neither the dhr review nor the product analysis suggests that the reported failure 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: 7907322
• MDR Text Key: 121723526
• Report Number: 3004939290-2018-00780
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)191130(10)F1733101
• 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: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: 1733101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1