MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; PERIPHERAL DILATATION CATHETER

Model Number	A1030-120
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a lesion in the left anterior tibial artery.No introducer sheath was utilized to access the artery.The 3.0x120mm armada 14 balloon dilatation catheter (bdc) was advanced with resistance noted due to the anatomy.The balloon was inflated twice and then removed; however, difficulty was again met at the access site.Once removed from the anatomy, the physician tested the device and a leak was noted in the shaft.The procedure was completed two additional armada devices.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported difficulty advancing and removing the device from the anatomy could not be replicated in a testing environment as it was based on operational context.The reported leak could not be confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported difficulty advancing and removing the device appear to be related to operational context; however, a conclusive cause for the reported leak could not be determined.It was reported that the device interacted with the patient¿s challenging anatomy such that difficulty advancing and removing the device was encountered.Additionally, leaks can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, loose connections, and interactions with other devices.In this case, a conclusive cause for the reported leak could not be determined since the complaint could not be confirmed during return analysis.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: PERIPHERAL DILATATION CATHETER
• 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: 21918704
• Report Number: 2024168-2025-04372
• Device Sequence Number: 21088168
• Product Code: DQY
• UDI-Device Identifier: 08717648155826
• UDI-Public: (01)08717648155826(11)220808(17)260131(10)2080841
• 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
• Report Date (Section B): 04/28/2025

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: 01/31/2026
• Device Model Number: A1030-120
• Device Catalogue Number: A1030-120
• Device Lot Number: 2080841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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: 88 YR
• Patient Sex: Male
• Patient Weight: 100 KG