MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; CATHETER, PERCUTANEOUS

Model Number	B1060-040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a de novo, mildly calcified, heavily tortuous av fistula lesion with 90% stenosis.A 6x40 mm armada 35 balloon dilatation catheter (bdc) was prepared before patient use as per the instructions for use without issue.The bdc was advanced to the target lesion for pre-dilation without resistance; however, the device could not be pressurized to 20 atmospheres and a leak was noted in the proximal shaft.An additional 6x40 mm bdc was used to complete the procedure.There were no adverse patient effects and there was 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.

• Brand Name: ARMADA¿
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 24837578
• Report Number: 2024168-2026-01467
• Device Sequence Number: 9221793
• Product Code: DQY
• UDI-Device Identifier: 08717648154690
• UDI-Public: (01)08717648154690(17)281231(10)50724G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 50724G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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