MAUDE Adverse Event Report: CARDINAL HEALTH MYNXGRIP (5F) VASCULAR CLOSURE DEVICE; MGB

Model Number MX5021

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/16/2015

Event Type  malfunction  

Manufacturer Narrative

An attempt to inflate the balloon with water revealed a leak.Visual inspection at high magnification confirmed that the source of the leak was a micro tear in the balloon, approximately 4.5 mm from the balloon proximal tip.Based on the information provided and the investigation performed, the root cause of the tear could not be conclusively determined.The review of the lhr (f1500501) indicated that the device lot met all established performance criteria prior to shipment.(b)(4).See medwatch form #s 3004939290-2015-00309 & 3004939290-2015-00310.

Event Description

The following information was reported: two device failures from the same lot number was used on the same patient.The balloon broke on the first device and the second device pulled through the arteriotomy.Manual compression of 30 minutes or less was applied to achieve hemostasis.The patient was not hospitalized.Sheath size: 5f.

• Brand Name: MYNXGRIP (5F) 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: 4893600
• MDR Text Key: 22441337
• Report Number: 3004939290-2015-00309
• 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: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2016
• Device Model Number: MX5021
• Device Lot Number: F1500501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• 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