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

Model Number	A2040-120
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a patent but damaged external iliac artery with occlusion of the common femoral artery with bypass.A.014 non-abbott guide wire failed to advance the deep formal artery; however, eventually advanced through the bypass.Pre-dilatation with a 4.0 x 120 mm armada 14 balloon was performed: however, the balloon ruptured leaving part of the balloon inside the bypass as confirmed with imaging.The separated portion of the balloon was attempted to be retrieved with a 5 x 100 mm armada balloon; however, this was unsuccessful.A longitudinal incision (arteriotomy) was made at the groin with dissection and control of the bypass to repair the common femoral artery and remove the separated portion of the balloon.There was no adverse patient sequela and clinically significant delay was noted.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a patent but damaged external iliac artery with occlusion of the common femoral artery with bypass.A.014 non-abbott guide wire failed to advance the the deep formal artery; however, eventually advanced through the bypass.Pre-dilatation with a 4.0x120mm armada 14 balloon was performed; however, the balloon ruptured leaving part of the balloon inside the bypass as confirmed with imaging.The separated portion of the balloon was attempted to be retrieved with a 5x100mm armada balloon; however, this was unsuccessful.A longitudinal incision (arteriotomy) was made at the groin with dissection and control of the bypass to repair the common femoral artery and remove the the separated portion of the balloon.There was no adverse patient sequela and clinically significant delay was noted.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis was performed on the returned device.The balloon rupture and separation were confirmed.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 the observations from the returned analysis, a definitive cause for the reported issue could not be determined.The subsequent treatment is related to the circumstances of the procedure.Based on observations from the returned analysis it is likely the observed mechanical damage to the balloon surface was incurred during advancement or during inflation due to possible calcification or in the bypass bifurcation leading to the rupture and radial separation; however, this cannot be confirmed.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.

• 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: 23526430
• Report Number: 2024168-2025-11467
• Device Sequence Number: 13268622
• Product Code: LIT
• UDI-Device Identifier: 08717648156168
• UDI-Public: (01)08717648156168(11)240925(17)280229(10)4092541
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: A2040-120
• Device Catalogue Number: A2040-120
• Device Lot Number: 4092541
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown