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

Model Number	1013465-060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
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 was performed to treat a mildly calcified lesion in the anterior tibial artery.A 3.0x60mm armada balloon dilatation catheter (bdc) was prepared and advanced to the lesion with no noted issues, and attempted to be used for vessel dilatation.However during the first inflation to 8atms the bdc was noted to be leaking from the shaft of the device near the y-port.Therefore the bdc was removed and the procedure was completed with the use of the another abbott device.There were no adverse patient effects nor clinical delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported leak was not confirmed.The balloon inflated and maintained pressure with no leaks observed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and observations from the returned analysis, a definitive cause for the reported leak could not be determined.Although what appeared to be inadequate adhesive visible in the proximal port of the sidearm, the area of the sidearm critical to maintain inflation appeared to be adequate and there were no leaks noted during functional testing after the device was soaked for 24 hours.The balloon inflated and maintained pressure with no leaks observed.Additionally, review of the manufacturing records confirmed that the unit had gone through multiple visual and physical inspections on the manufacturing line, including a leak testing.It may be possible that during use, the inflation device was not properly connected resulting in leak; however, this could not be confirmed.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: 23090690
• Report Number: 2024168-2025-10015
• Device Sequence Number: 16077781
• Product Code: LIT
• UDI-Device Identifier: 08717648207877
• UDI-Public: (01)08717648207877(17)251031(10)2050641
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 11/12/2025

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: 10/31/2025
• Device Model Number: 1013465-060
• Device Catalogue Number: 1014254-180
• Device Lot Number: 2050641
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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