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

Model Number	A2040-060
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2024
Type of Reportable Event	Malfunction
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 70% stenosed lesion in the popliteal artery with moderate calcification and moderate tortuosity.After a command es guide wire (gw) crossed the target lesion, the 4x60mm armada 14 balloon dilation catheter (bdc) was advance to the target lesion and the balloon was inflated to nominal pressure; however, the balloon could not be completely inflated.The hub of the bdc was then noted to have leakage; therefore, the bdc was removed from the patient.A 4x80mm armada balloon was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported complaints could not be determined.Possible factors that may contribute to a leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, damage to the balloon or loose connections.In this case, it may be possible that the sidearm and or inflation port within the sidearm was damaged resulting in the reported leak and subsequently the inflation issue; however, without having the device to examine, a conclusive cause could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: d9 - device available for evaluation updated from yes to no.

• 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: 21170920
• Report Number: 2024168-2025-00640
• Device Sequence Number: 11825140
• Product Code: LIT
• UDI-Device Identifier: 08717648156144
• UDI-Public: (01)08717648156144(11)230227(17)260731(10)3022741
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Expiration Date: 07/31/2026
• Device Model Number: A2040-060
• Device Catalogue Number: A2040-060
• Device Lot Number: 3022741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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: COMMAND ES GUIDE WIRE.
• Patient Sex: Unknown