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

Model Number	B1050-040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
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.
Event or Problem Description
It was reported that the procedure performed was to treat a mildly calcified superficial femoral artery.During inflation of a 5x40mm armada 35 balloon, contrast was leaking from the catheter hub and the required pressure could not be reached.There was no damage observed on the balloon.A new armada 35 balloon was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and scanning electron microscopy (sem) analysis were performed on the returned device.The reported leak was confirmed.The production record review was performed and revealed no indication of a product quality issue.The corrective and preventive actions (capa) review was performed and revealed capa issues related to the reported issue; indicating there is a potential product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The investigation determined a potential product quality issue based on evaluation of the returned unit and the review of the corrective and preventive actions (capa) database.The leak was observed coming out of the stain relief tubing.It was determined the device leakage from the distal end of the luer may possibly be attributed to a material/processing discrepancy.A gap/channel was observed between the shaft and adhesive at the distal adhesive bond area.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 22933262
• Report Number: 2024168-2025-09328
• Device Sequence Number: 18739313
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: (01)08717648154607(17)280430(10)41107G2
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 41107G2
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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