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

Model Number	B2050-150
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.During preparation of the 5x150mm armada 35 balloon dilatation catheter (bdc), air aspiration was not able to be completed using the unspecified inflation device.Therefore, another inflation device was attempted to be used for air aspiration, but the second inflation device also was not able to create suction to prepare the balloon.The physician manually prepared the balloon with contrast and attached the inflation device to use the bdc in the procedure.The bdc was advanced to the target lesion and an attempt was made to inflate the balloon; however, a contrast leak was noted the connection point of the balloon catheter and hub.Therefore, the bdc was removed from the patient.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported inflation issue and leak 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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported complaints 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.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.In this case, a conclusive cause for the reported leak and inflation issue could not be determined since the complaints could not be confirmed during return analysis.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: 23203771
• Report Number: 2024168-2025-10718
• Device Sequence Number: 9989004
• Product Code: LIT
• UDI-Device Identifier: 08717648155222
• UDI-Public: (01)08717648155222(17)280630(10)50103G2
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/04/2025

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: B2050-150
• Device Catalogue Number: B2050-150
• Device Lot Number: 50103G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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 Sex: Unknown