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

Model Number	QL2530
Medical Device Problem Codes	No Device Output (1435); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INFLATION DEVICE
• Manufacturer (Section D): ATRION MEDICAL PRODUCTS, INC.; 1426 curt francis road; arab AL 35016
• MDR Report Key: 8424304
• Report Number: 1043729-2019-00001
• Device Sequence Number: 16726199
• Product Code: MAV
• UDI-Device Identifier: 00856877002025
• UDI-Public: 00856877002025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: QL2530
• Device Catalogue Number: 96402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other