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

Model Number	B2050-200
Medical Device Problem Codes	Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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
T was reported that during preparation of the 5x200 mm armada 35 percutaneous transluminal angioplasty (pta) catheter, the balloon was noted to have a pinhole and a small kink in the balloon.The device was not used and there was no patient involvement.A new, same size armada was used to complete the procedure.There was 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 as a balloon rupture was noted and the device would not hold pressure.Additionally, it is likely that the noted scratch in the balloon on the returned device is what the account perceived as the reported kink.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 a potential product quality issue based on the evaluation of the returned device.During scanning electron microscopy (sem) analysis the balloon exhibited a rupture with a radial to longitudinal transition.Smearing, tearing and damage were documented at the rupture edges.The area of the reported pinhole revealed damage and tearing intersecting a balloon fold.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
Event or Problem Description
T was reported that during preparation of the 5x200 mm armada 35 percutaneous transluminal angioplasty (pta) catheter, the balloon was noted to have a pinhole and a small kink in the balloon.The device was not used and there was no patient involvement.A new, same size armada was used to complete the procedure.There was no clinically significant delay in the procedure.Subsequent to the initially filed report it was stated that the balloon was attempted to be inflated after removing from the hoop on the back table a few atmospheres.No additional information was provided.

• 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: 22046897
• Report Number: 2024168-2025-05215
• Device Sequence Number: 21057569
• Product Code: LIT
• UDI-Device Identifier: 08717648155239
• UDI-Public: (01)08717648155239(17)271130(10)40626G1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 09/15/2025

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: B2050-200
• Device Catalogue Number: B2050-200
• Device Lot Number: 40626G1
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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