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

Model Number	B1070-040
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat bilateral de novo, heavily calcified, moderately tortuous common iliac artery (cia) lesions, each with 100% stenosis.Each side (left and right cia) was accessed via ipsilateral femoral access using a 6f sheath and crossed with a 0.035-inch guidewire.During advancement of the 5.0x40mm armada 35 balloon dilatation catheter (bdc), resistance was met due to anatomy.Once at the right cia lesion for predilation, the balloon ruptured at 8 atmospheres during the first inflation.A second balloon of the same size was used successfully to complete predilation.The procedure was then performed on the contralateral cia.During advancement of the 7.0x40mm armada 35 bdc, resistance was met due to anatomy.Once at the left cia lesion for predilation, the balloon also ruptured at approximately 8 atmospheres during the first inflation.A new 7.0x40mm armada 35 balloon was subsequently used to complete predilation.A non-abbott stent was then successfully deployed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported complaints appear to be related to operational context.There was no leak noted to the balloon during preparation, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the moderately tortuous and heavily calcified anatomy resulting in the reported difficulty advancing the device and subsequently the balloon became damaged and ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional device referenced in b5 is being filed under a separate medwatch report number.

• 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: 25410930
• Report Number: 2024168-2026-02290
• Device Sequence Number: 21221609
• Product Code: DQY
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782(17)290331(10)51016G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 51016G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• 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