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

Model Number	B1060-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a lesion in the subclavian artery.The 6.0x40mm armada 35 balloon dilatation catheter was advanced to the target lesion however during inflation to nominal pressure, it was noted air was flowing back in the indeflator, the physician suspected a leak.The device was removed and another same size armada 35 was used however the same issue occurred.The device was removed and the procedure completed using a third armada 35.There were no adverse patient effects and no clinically significant delay 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, functional testing, and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture was not confirmed; however, it is likely that the noted leak at the distal end of the strain relief is what the account perceived as the balloon rupture since the device would not hold pressure.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 quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.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 distal end of the strain relief.It was determined the device leakage from the distal end of the luer was attributed to gaps in the adhesive bond area just below and at the leak areas.Additionally, it is likely that the noted leak at the distal end of the strain relief is what the account perceived as the reported balloon rupture, since the device would not hold pressure.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
Event or Problem Description
It was reported the procedure was to treat a lesion in the subclavian artery.The 6.0x40mm armada 35 balloon dilatation catheter was advanced to the target lesion however during inflation to nominal pressure, it was noted air was flowing back in the indeflator, the physician suspected a leak.The device was removed and another same size armada 35 was used however the same issue occurred.The device was removed and the procedure completed using a third armada 35.There were no adverse patient effects and no clinically significant delay in the procedure.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: 23816085
• Report Number: 2024168-2025-12062
• Device Sequence Number: 21323038
• Product Code: LIT
• UDI-Device Identifier: 08717648154690
• UDI-Public: (01)08717648154690(17)280731(10)50211G1
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/24/2026

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: B1060-040
• Device Catalogue Number: B1060-040
• Device Lot Number: 50211G1
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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