MAUDE Adverse Event Report: ATRION MEDICAL PRODUCTS INC. ATRION QL38 LOCKING SYRINGE DEVICE; BALLOON CATHETER INFLATION DEVICE

Model Number	96406
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received on 9/19/2025 reporting: "as reported by the field clinical specialist, during a transfemoral transcatheter aortic valve replacement procedure with a 29mm sapien 3 valve, the indeflator locked up after inflation.The balloon could not be deflated using the indeflator and had to be deflated manually.".A pcr was opened and an investigation launched to determine the potential root cause and whether corrective action was necessary.A second complaint from the same lot was received on 11/07/2025 stating: as reported by the field clinical specialist (fcs), during a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29 mm sapien 3 ultra resilia valve, while deploying the valve, the indeflator would not pull negative to come down on the balloon.The locking mechanism would not release the threaded portion of the indeflator plunger.It was confirmed that the atrion ql38 was unlocked when trying to pull negative to deflate the balloon, but it would not release.The indeflator was quickly disconnected from the delivery system, allowing the balloon to passively empty.A 50 cc syringe was quickly attached to the delivery system stopcock and pulled negative to fully deflate the delivery system balloon.Pacing was maintained during this issue and the total pacing time was 42 seconds.The patient recovered quickly and left the operating room (or) in stable condition.".

• Brand Name: ATRION QL38 LOCKING SYRINGE DEVICE
• Common Device Name: BALLOON CATHETER 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 ; 2565861580
• MDR Report Key: 24179841
• Report Number: 1043729-2026-00001
• Device Sequence Number: 10016394
• Product Code: OEQ
• UDI-Device Identifier: 00856877002032
• UDI-Public: 00856877002032
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 96406
• Device Catalogue Number: 96406
• Device Lot Number: 96406A101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 29 MM SAPIEN 3 ULTRA RESILIA VALVE; EDWARDS LIFESCIENCES 29MM SAPIEN 3 VALVE; EDWARDS LIFESCIENCES 29MM SAPIEN 3 VALVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown