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

Model Number	A2020-120
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was treat a distal posterior tibial artery that was mildly calcified.After the diamondback 360 was used successfully.An armada 14 balloon was inserted along with the viperwire.During removal of the guide wire, the tip met resistance with the balloon and became stuck in the shaft of the balloon.An attempt was made to remove the devices independently; however, was unsuccessful.Both devices were removed together.The balloon shaft was observed to be folded like an accordion once outside the anatomy.A 2.0x150 armada and an non-abbott guide wire were used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay 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 resistance with the guide wire may include, but are not limited to, device placement technique, introducer sheath support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.A conclusive cause for the reported complaint could not be determined since the device or component were not returned for analysis.Additionally, it is possible that manipulation of the device contributed to the reported balloon shaft being folded like an accordion; however, a conclusive cause cannot be determined.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21396055
• Report Number: 2024168-2025-01765
• Device Sequence Number: 13072668
• Product Code: DQY
• UDI-Device Identifier: 08717648155987
• UDI-Public: (01)08717648155987(17)261130(10)3062941
• 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): 02/17/2025

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: A2020-120
• Device Catalogue Number: A2020-120
• Device Lot Number: 3062941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• 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: VIPERWIRE.
• Patient Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 103 KG