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

Model Number MX5021

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the provided information and without the return of the device, the reported event could not be confirmed and the root cause could not be determined.The review of the lot history record indicated that the added inspection step on adhesive taper did not cause or contribute to the reported incident and the lot met all product specifications, including quality control acceptance criteria and sterilization prior to shipment.Should additional relevant information become available, a supplemental medwatch report will be filed.

Event Description

It was reported that the mynxgrip 5f vascular closure device failed to deploy the sealant.The mynx device was being used for arterial closure in conjunction with a 5f procedural sheath following a diagnostic procedure.The user shuttled down completely without significant resistance.During the sheath pull back, the sealant got lodged in end of black shuttle tube and tamp tube wasn't visible.Sealant had swelled at end of shuttle tube.No unusual force was applied when retracting the sheath.The patient's hospitalization was not extended.The patient was noted to have recovered with no complications.Additional information was requested, but was unknown.

• 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 ; 4056106500
• MDR Report Key: 6201557
• MDR Text Key: 63193275
• Report Number: 3004939290-2016-00350
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: MX5021
• Device Lot Number: F1625002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• 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: 5F ST. JUDE SHEATH; DIAGNOSTICS BOSTON SCIENTIFIC CATHETERS
• Patient Age: 56 YR
• Patient Weight: 86