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

Model Number QL®2530

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/13/2020

Event Type  Injury  

Event Description

Complaint description: during the transfemoral tavr procedure for a 26mm sapien 3 valve, threaded plunger of atrion inflation device ql2530 part number 96402 broke off.After the valve was deployed, the operator pulled the plunger to deflate the balloon.Then the plunger broke off and separated from the piston.The balloon was deflated only -2ml.The device was replaced with the other inflation device which was used for pre-dilation.As the rapid pacing was executed for longer time, ventricular fibrillation (vf) occurred.Defibrillation and cardiac massage were done and adrenaline was given.The blood pressure was back to normal and there was no other complication.The patient was returned to icu.The physician stated that the situation could be fatal when the balloon could not be deflated.Description of problem: a photo of the complaint device was received with the complaint, which reveals that the black plunger component of the balloon inflation syringe separated from the piston and was removed from the device.The plunger tip which snap fits and locks the plunger to the piston exhibited an injection molding defect know as a short or non-fill.This short or non-fill means the plunger was not completely formed during manufacture.The plunger's piston snap fit retention feature was not fully formed due to the short non filled plunger component allowing the plunger to separate from the piston when the plunger was pulled back to create vacuum within the device to collapse a balloon catheter attached to the balloon inflation syringe.

• Brand Name: ATRION MEDICAL QL INFLATION DEVICE
• Type of Device: BALLOON INFLATION SYRINGE
• Manufacturer (Section D): ATRION MEDICAL PRODUCTS, INC.; 1426 curt francis road; arab, al
• Manufacturer (Section G): ATRION MEDICAL PRODUCTS, INC.; 1426 curt francis road; arab, al
• Manufacturer Contact: daniel swantner ; 1426 curt francis road; arab, al
• MDR Report Key: 10112641
• MDR Text Key: 195168583
• Report Number: 1043729-2020-00001
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00856877002025
• UDI-Public: 00856877002025
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: QL®2530
• Device Catalogue Number: 96402
• Device Lot Number: 96402298
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2019
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 60