MAUDE Adverse Event Report: ATRION MEDICAL PRODUCTS, INC. QL INFLATION DEVICE

Model Number QL2530

Device Problems No Device Output (1435); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

A lot number was not reported for this complaint, however, valve serial numbers were provided to atrion.The kits that the valve serial numbers were associated with contained inflation devices from lots 96402244 and 96402249.A review of the device history records for the two lots indicated that the devices were manufactured under normal operating procedures.All final assembly devices were sampled, inspected, and accepted per (b)(4).The device was not returned so a functional investigation could not be conducted.A review of the device history record for lots 96402244 and 96402249 revealed everything met the acceptance criteria.Additionally all inflation devices are 100% tested with ultra-high purity nitrogen gas for functional compliance of the gauge, pressure tested, and vacuum tested during manufacture.Each device is checked for proper gauge orientation, gauge responsiveness to pressure, gauge pressure accuracy (from vacuum to maximum gauge capacity), and device seal integrity.There has been no confirmed complaints in the past 5 years for a gauge not responding to pressure for this device.The instructions for use (ifu) for deployment of the valve instruct that the valve is to be deployed by means of a set fluid volume, not by fluid pressure.The valve ifu does not indicate that the pressure gauge should be used.

Event Description

As reported to atrion: during deployment of a valve in the aortic position, the physician looked at the pressure reading on the atrion device to ensure as to not cause an annular rupture.The atrion pressure gauge did not show any pressure reading, however the balloon and valve were inflated.A lot number was not reported for this complaint, however, valve serial numbers were provided to atrion.The kits that the valve serial numbers were associated with contained inflation devices from lots 96402244 and 96402249.A review of the device history records for the two lots indicated that the devices were manufactured under normal operating procedures.All final assembly devices were sampled, inspected, and accepted per (b)(4).The device was not returned so a functional investigation could not be conducted.A review of the device history record for lots 96402244 and 96402249 revealed everything met the acceptance criteria.Additionally all inflation devices are 100% tested with ultra-high purity nitrogen gas for functional compliance of the gauge, pressure tested, and vacuum tested during manufacture.Each device is checked for proper gauge orientation, gauge responsiveness to pressure, gauge pressure accuracy (from vacuum to maximum gauge capacity), and device seal integrity.There has been no confirmed complaints in the past 5 years for a gauge not responding to pressure for this device.The instructions for use (ifu) for deployment of the valve instruct that the valve is to be deployed by means of a set fluid volume, not by fluid pressure.The valve ifu does not indicate that the pressure gauge should be used.

• Brand Name: QL INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): ATRION MEDICAL PRODUCTS, INC.; 1426 curt francis road; arab AL 35016
• Manufacturer Contact: daniel swantner ; 1426 curt francis road; arab, AL 35016 ; 2563172228
• MDR Report Key: 8424304
• MDR Text Key: 138905417
• Report Number: 1043729-2019-00001
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00856877002025
• UDI-Public: 00856877002025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QL2530
• Device Catalogue Number: 96402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/15/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 93 YR