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

Model Number	A2040-200
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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 medical device problem code: 2017: contrast incorrect.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the superficial femoral artery (sfa).A 4.0 x 200 mm armada 14 balloon dilatation catheter (bdc) was advanced into the anatomy; however, both the distal and proximal markers could not be seen under fluoroscopy when 70% contrast was used.Therefore, the bdc was not used and the device was replaced with a non-abbott device to continue the procedure.There were no adverse patient effects nor clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported complaint was not confirmed.A balloon rupture was noted on the returned device.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.It was reported by the account that the contrast ratio used in the procedure was 70% contrast and 30% heparinized saline.It should be noted that the pta catheter, armada 14, global, instructions for use (ifu), materials required section, specifies that the contrast is 60% contrast diluted 1:1 with normal saline.Contrast that is more concentrated can lead to slower inflation and deflation times.In this case, it is unknown if the use of slightly more contrast than heparinized saline caused or contributed to the reported complaint.Based on the reported information and the observations from the returned device analysis, a definitive cause for the reported complaint could not be determined.Possible factors that may cause the balloon markers to not be visible under fluoroscopy include, but not limited to, the type of contrast solution, patient anatomy, patient disease state, fluoroscopy equipment, and the angle of the x-ray tube on the patient.In this case, a conclusive cause for the reported complaint cannot be determined since the complaint could not be confirmed during returned device analysis.Additionally, returned device analysis noted a balloon rupture on the returned device.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices or lesion calcification.In this case, a conclusive cause for the noted balloon rupture could not be determined since limited information was provided and the account did not respond to follow up.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: 21857199
• Report Number: 2024168-2025-03970
• Device Sequence Number: 4695766
• Product Code: LIT
• UDI-Device Identifier: 08717648156175
• UDI-Public: (01)08717648156175(11)220927(17)260228(10)2092741
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/05/2025

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: 02/28/2026
• Device Model Number: A2040-200
• Device Catalogue Number: A2040-200
• Device Lot Number: 2092741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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