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

Model Number	A2025-200
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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.H6: device code 2017- contrast incorrect.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the tibioperoneal trunk with calcification.The 2.5x200 mm armada percutaneous transluminal angioplasty (pta) catheter did not fully deflate after use.The contrast mix was 1/3 saline, 1/3 contrast and the balloon was inflated to nominal pressure.The device was withdrawn inflated.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report it was reported the contrast ratio was 1/3 contrast to 2/3 saline.The balloon was inflated once and negative pressure was held for 15 seconds.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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.It was reported that the contrast mix used in the procedure was 1/3 contrast to 2/3 saline.It should be noted that the pta catheter, armada 14, global, instructions for use ifu, specified that the contrast is 60% contrast diluted 1:1 with normal saline.In this case, since 1/3 contrast to 2/3 saline ration was used and is less contrast concentration than the required percentage, it is unknown if the ifu violation caused or contributed to the reported complaint.Based on the information provided, a definitive cause for the reported deflation issue could not be determined.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A conclusive cause for the reported deflation issue could not be determined since the device was not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5 - describe event or problem: updated.

• 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: 21057007
• Report Number: 2024168-2025-00027
• Device Sequence Number: 18306802
• Product Code: DQY
• UDI-Device Identifier: 08717648156052
• UDI-Public: (01)08717648156052(17)270531(10)3122041
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 01/17/2025

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: A2025-200
• Device Catalogue Number: A2025-200
• Device Lot Number: 3122041
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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
• Patient Sex: Unknown