MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number A2025-120

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Device code 2017 - incorrect prepna.

Event Description

It was reported that during preparation the 2.5/120 mm armada 14 percutaneous transluminal angioplasty (pta) catheter was inflated and the device would not fill up prior being used on the patient.Another armada was used to complete the procedure.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported that the balloon was inflated during preparation and before entering the patient anatomy.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 14, global, instructions for use (ifu) states the steps to air aspirate the device and slowly release device pressure to neutral.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint since the device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16546555
• MDR Text Key: 311915750
• Report Number: 2024168-2023-02693
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156045
• UDI-Public: 08717648156045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2025-120
• Device Catalogue Number: A2025-120
• Device Lot Number: 1120941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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