MAUDE Adverse Event Report: ATRION MEDICAL PRODUCTS, INC. ATRION QL38; 17541, CATHETER BALLOON INFLATION SYSTEM, SINGLE-USE

Model Number QL38

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

A complaint was received reporting: "as reported by a field clinical specialist (fcs), during valve deployment of a 29 mm sapien 3 valve in the native aortic valve via transfemoral approach, the atrion ql38 inflation device cracked with approximately 3cc still in the inflation device.A 20cc syringe was connected to the delivery system to complete the deployment.A second atrion ql38 was open and used to insure the valve was fully inflated.Currently the device is with r&d for ct scanning, and we plan to conduct similar diagnostics as the previous investigation.".

• Brand Name: ATRION QL38
• Type of Device: 17541, CATHETER BALLOON INFLATION SYSTEM, SINGLE-USE
• Manufacturer (Section D): ATRION MEDICAL PRODUCTS, INC.; 1426 curt francis road; arab AL 35016
• Manufacturer (Section G): 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: 15495497
• MDR Text Key: 306352557
• Report Number: 1043729-2022-00001
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00856877002032
• UDI-Public: 00856877002032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QL38
• Device Catalogue Number: 96406
• Device Lot Number: 96406A033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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 Sex: Male