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

Model Number	B2040-200
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
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 - use after damage.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, mildly tortuous left superficial femoral artery lesion.During preparation while performing air aspiration of the 4x200 mm armada 35 balloon dilatation catheter (bdc) air was noted.The physician turned the balloon negative multiple times to suck in the air; however continuous air was noted.However, the physician decided to use the balloon anyway.The bdc was advanced to the target lesion for pre-dilation without issue.Inflation was noted to be slow, but the balloon was able to fully inflate.The bdc was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported leak and inflation issue were not confirmed.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 that a leak and inflation issue were noted on the device during preparation and the device was used in the procedure.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu) states: perform steps 1-7 to remove all air and verify the integrity of the pta catheter.In this case, it is not likely that the ifu violation contributed to the reported complaint as the device was successfully used and the complaint could not be confirmed during return analysis.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported leak and inflation issue could not be determined.Possible factors that can contribute to a leak in the system include, but are not limited to, manufacturing, balloon damage during use, inflation technique, interactions with accessory devices, catheter damage, or insufficient preparation prior to use.Additionally, possible factors that may contribute to difficulty inflating may include, but are not limited to, manufacturing, damage to the inflation lumen, patient anatomical morphology and patient disease state.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 COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 24435916
• Report Number: 2024168-2026-00761
• Device Sequence Number: 10244650
• Product Code: LIT
• UDI-Device Identifier: 08717648155147
• UDI-Public: (01)08717648155147(17)280731(10)50217G1
• Combination Product (Y/N): N
• PMA/510(K) Number: K111899
• 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): 03/27/2026

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: B2040-200
• Device Catalogue Number: B2040-200
• Device Lot Number: 50217G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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 Age: 83 YR
• Patient Sex: Female