MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	A1040-120
Medical Device Problem Codes	Material Rupture (1546); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat an occluded, heavily calcified, mildly tortuous popliteal artery using a 4gx25cm hi-torque (ht) command 14 guidewire and a 2.0x20mm armada 14 xt balloon dilatation catheter (bdc).The ht command guidewire and armada 14 bdc stuck together during removal and were withdrawn as one unit.A 4.0x120mm armada 14 percutaneous transluminal angioplasty (pta) bdc was to be used in the heavily calcified, mildly tortuous left interior tibial.During advancement of the armada 14 pta bdc, resistance was met due to anatomy.Once at the lesion, the armada 14 pta bdc was inflated once to 6 atmospheres and collapsed on itself like an accordion.The procedure was terminated and it is unknown if other devices were used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional devices referenced in b5 are filed under separate medwatch report numbers.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported difficulty advancing was not tested due to the condition of the returned unit and the difficulty was related to procedural circumstances.The ¿balloon collapsing¿ was not confirmed as the balloon catheter was inflated and maintained pressure with no issues.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and observations from the returned analysis, the difficulty advancing and reported difficulty of the ¿balloon collapsing¿ during inflation was likely due to challenging anatomical conditions which were reported as occluded, heavily calcified, and mildly tortuous.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: medical device problem code 1546 removed, 2889 added.
Event or Problem Description
Subsequently, there were no reports of a balloon rupture, only that the armada 14 bdc collapsed on itself like an accordion.No additional information was provided.

• Brand Name: ARMADA¿
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22362266
• Report Number: 2024168-2025-06701
• Device Sequence Number: 18217857
• Product Code: LIT
• UDI-Device Identifier: 08717648155888
• UDI-Public: (01)08717648155888(11)240322(17)270831(10)4032241
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: A1040-120
• Device Catalogue Number: A1040-120
• Device Lot Number: 4032241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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
• Patient Sex: Unknown