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

Model Number MX6740

Device Problem Device Slipped (1584)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/29/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned device revealed that there was no saline in the balloon.The balloon was fully inflated with water and pressure was maintained.The inflation indicator performed per specification.No leaks were observed.The inflated balloon diameter was also verified in a go/no go gauge to be within specification.Based on the information provided and the investigation performed, the root cause of the reported event could have been incorrect prep of the balloon.Per the mynx ace instructions for use (ifu), the device needs to be purged of air by drawing vacuum with 2-3 ml of sterile saline prior to use.Failure to purge the device of air during the prep phase can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and resulting in the balloon pulling through the arteriotomy.There is no evidence to suggest that the mynx ace vascular closure device did not meet specification or perform as intended per the ifu.The review of the lhr ((b)(4)) indicated that the device lot met all established performance criteria prior to shipment.(b)(4).

Event Description

The following information was reported by the company representative: i was just contacted in regards to this device as the new company representative on the account.It has been sitting on their shelf for return for some time.There is an issue with the balloon and the device pulling out but the doctors do not remember the details.Manual compression was applied for less than 15 minutes.

Manufacturer Narrative

Visual inspection of the returned device revealed that there was no saline in the balloon.The balloon was fully inflated with water and pressure was maintained.The inflation indicator performed per specification.No leaks were observed.The inflated balloon diameter was also verified in a go/no go gauge to be within specification.Based on the information provided and the investigation performed, the root cause of the reported event could have been incorrect prep of the balloon.Per the mynxgrip instructions for use (ifu), the device needs to be purged of air by drawing vacuum with 2-3 ml of sterile saline prior to use.Failure to purge the device of air during the prep phase can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and resulting in the balloon pulling through the arteriotomy.There is no evidence to suggest that the mynxgrip device did not meet specification or perform as intended per the instructions for use (ifu).The review of the lhr (f1422003) indicated that the device lot met all established performance criteria prior to shipment.(b)(4).

• Brand Name: MYNX ACE (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: 4856891
• MDR Text Key: 14252141
• Report Number: 3004939290-2015-00269
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: MX6740
• Device Lot Number: F1422003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• 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