MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN; MGB

Device Problems Difficult to Insert (1316); Device Slipped (1584)

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

Event Type  malfunction  

Event Description

The following information was reported: the patient was being closed with a mynx device.The physician was shuttling down and said he felt the device/balloon "relocate".This feeling of movement was very disturbing to the physician.He aborted the mynx closure procedure, and immediately checked distal pulses and performed ultrasound of the site to see if any sealant had been introduced into the patient's femoral artery.It was determined by the physician that no sealant had been delivered into the patient's vessel.Manual pressure was held for 20 minutes, hemostasis was achieved and there were no further access related issues with this patient.Procedure type: intervention peripheral vessel type: arterial.

Manufacturer Narrative

The device was not returned; therefore, a physical investigation could not be performed.Based on the information provided, the reported event could not be confirmed and the root cause could not be determined.A review of the lhr was not possible as the lot number was not provided.Di and pi numbers are unknown as the part number and lot number were not provided.

• Brand Name: UNKNOWN
• 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: 4848898
• MDR Text Key: 5807105
• Report Number: 3004939290-2015-00262
• 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
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• 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