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

Model Number	A2025-200
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that during preparation, and before use in the patient, when negative was pulled on the armada 14 balloon, there was a hole [tear] in the balloon and air bubbles continued to fill.A new armada was used to continue the procedure without further issue.No additional information was provided.
Additional Manufacturer Narrative
D4 correction: model number entered.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.
Additional Manufacturer Narrative
D1 correction: updated device brand name to align with the information in the corresponding fields in gudid.

• 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: 18360558
• Report Number: 2024168-2023-14237
• Device Sequence Number: 20811509
• Product Code: DQY
• UDI-Device Identifier: 08717648156052
• UDI-Public: (01)08717648156052(17)251130(10)2062741
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 11/30/2025
• Device Model Number: A2025-200
• Device Catalogue Number: A2025-200
• Device Lot Number: 2062741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 06/12/2024; 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 06/24/2024; 06/24/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2022
• 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 Sex: Unknown