MAUDE Adverse Event Report: CARDINAL HEALTH MYNXGRIP 6F/7F VASCULAR CLOSURE DEVICE; MGB

Model Number MX6721

Device Problems Positioning Failure (1158); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned; therefore, a physical investigation was not performed and the reported event could not be confirmed.A lot history review was not possible as the lot number was not provided.However, product release at cardinal health is contingent upon the successful completion of lot release testing and a documentation review by the quality department.Based on the information provided and no returned device for physical investigation, the reported event could not be confirmed and the root cause could not be determined.However, it was reported that the user believed that the calcified lesion at the arteriotomy caused the distal tip of the 6f avanti procedural sheath to become disfigured causing the advancer tube to not engage.It should be noted that per the mynxgrip instructions for use (ifu), the safety and effectiveness of mynx have not been established in patients with clinically significant peripheral vascular disease in the vicinity of the puncture site.Should additional relevant information become available a supplemental mdr will be filed.Udi number: device identifier (di): (b)(4).Production identifier (pi) number is unknown as the lot number was not provided.

Event Description

It was reported that the advancer tube of a mynxgrip 6f/7f vascular closure device was not present when the procedural sheath was withdrawn from the tissue tract.There were 2 sheath exchanges.The mynx device was being used in conjunction with a 6f procedural sheath following an interventional peripheral procedure.The user reported that it was believed that the calcified lesion at the arteriotomy caused the distal tip of the procedural sheath to become disfigured causing the advancer tube to not engage.Manual compression was applied for 20 minutes to achieve hemostasis.The patient's hospitalization was not extended due to the mynx.There was no injury to the patient.Additional information was requested, but was unknown.

• Brand Name: MYNXGRIP 6F/7F VASCULAR CLOSURE DEVICE
• Type of Device: MGB
• Manufacturer (Section D): CARDINAL HEALTH; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: librada contreras ; 5452 betsy ross drive; santa clara, CA 95054 ; 4086106500
• MDR Report Key: 6176145
• MDR Text Key: 62434840
• Report Number: 3004939290-2016-00345
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MX6721
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F AVANTI PROCEDURAL SHEATH; HEPARIN; PROTAMINE