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

Model Number	1013470-100
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a lesion in the superficial femoral artery (sfa).The 6.0x100mm armada 18 balloon dilatation catheter was advanced into the patient anatomy and air aspiration performed.The balloon was inflated to 8 atmospheres three times.The balloon would not fully deflate and could not be removed through the sheath.The balloon catheter and sheath were removed as a single unit and the procedure completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6 medical device problem code: 2017 - incorrect prep, 2017 - failure to follow steps / instructions.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.The investigation determined the reported deflation issues appears to be related to user error.It was reported that the contrast ration used in the procedure was 70 % contrast and 30 % saline.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 18, ce, instructions for use (ifu) specified that the contrast is diluted 1:1 with normal saline.Contrast that is more concentrated can lead to slower inflation and deflation times.In this case, it is likely that the concentrated contrast solution contributed to the reported deflation issue.The reported difficulty removing the device appears to be related to circumstances of the procedure.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: 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: 21606023
• Report Number: 2024168-2025-02655
• Device Sequence Number: 21049751
• Product Code: LIT
• UDI-Device Identifier: 08717648208423
• UDI-Public: (01)08717648208423(17)271231(10)4071041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 03/14/2025

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: 1013470-100
• Device Catalogue Number: 1013470-100
• Device Lot Number: 4071041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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 Sex: Unknown