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

Model Number	A2025-120
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
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 non-uniform balloon refold (winged) include, but not limited to, large balloon profile, deflation technique, multiple inflations.Possible factors that can contribute to difficult to remove/resistance with the introducer sheath post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends, procedural technique, insufficient support or interactions with other devices.In this case, a conclusive cause for the reported complaints could not be determined since the device or component were not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left peroneal artery.The 2.5x120mm armada 14 balloon dilatation catheter (bdc) was used on the procedure without issue; however, during removal of the bdc resistance was felt with the tip of the sheath.Therefore, the bdc, sheath and guide wire removed as a single unit.After removal the balloon was noted to be loosely folded.There was no adverse patient effect and no clinically significant delay reported in the procedure.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: 22118061
• Report Number: 2024168-2025-05534
• Device Sequence Number: 17880262
• Product Code: LIT
• UDI-Device Identifier: 08717648156045
• UDI-Public: (01)08717648156045(11)241111(17)280430(10)4111141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/30/2025

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: A2025-120
• Device Catalogue Number: A2025-120
• Device Lot Number: 4111141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG