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

Model Number MX6721

Device Problems Positioning Failure (1158); Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned; therefore, a physical investigation could not be performed.The review of the lot history record ((b)(4)) indicated that there were no reworks, special conditions or related non-conformances for this lot.The lot met all product specifications, including quality control acceptance criteria prior to release.Based on the information provided, the reported event could not be confirmed and the root cause could not be determined.However, it was reported that the facility used the mynxgrip device that had an expiration date of 3/31/2016 on 4/11/2016 which was beyond expiration date.It should be noted that the safety and effectiveness of mynxgrip is dependent on using the device within the allotted shelf life.Should additional relevant information become available a supplemental mdr will be filed.

Event Description

It was reported that the mynxgrip device failed to deploy correctly.The device was being used with a 6f procedural sheath for arterial closure following an interventional procedure.The user shuttled down completely.Significant resistance was not felt when shuttling down.Unusual force was not applied when retracting the sheath.A femostop was placed to achieve hemostasis.The patient's hospitalization was not prolonged as a result of the event.The patient was reported to be uncomfortable but fine following the event.

• 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: 5634104
• MDR Text Key: 44492815
• Report Number: 3004939290-2016-00132
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2016
• Device Model Number: MX6721
• Device Lot Number: F1508302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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: UNSPECIFIED STENT IN THE CORONARY ARTERY
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 127