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

Model Number	B1050-080
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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.H6: medical device problem code 2017: incorrect prep.
Event or Problem Description
It was reported the procedure was to treat a mildly calcified lesion in the left superficial femoral artery.The 5.0x80mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon prepped for use.When the balloon was inflated, it was noted to be leaking contrast and not holding pressure.The bdc was removed and the procedure completed using another balloon.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 hub 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 and a review of the complaint history of the reported lot revealed similar complaints from this lot, indicating there is a potential quality issue.It was reported that the device was not prepared (air aspiration) outside the anatomy.It should be noted that the percutaneous transluminal angioplasty (pta) armada 35 / armada 35 ll, global, instruction for use (ifu) indicates to perform the steps to remove all air and verify the integrity of the pta catheter.Leave the catheter under negative pressure until the balloon is at the target lesion site.Then the device can be introduced the device into the vascular system.In this case, it is unlikely that the violation of the instructions for use (ifu) caused or contributed to the reported complaint.The investigation determined a potential product quality issue based on evaluation of the returned unit, the review of the corrective and preventive actions (capa) database and similar complaint review.The leak was observed coming out of the distal end of hub 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 hub 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 mildly calcified lesion in the left superficial femoral artery.The 5.0x80mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon prepped for use.When the balloon was inflated, it was noted to be leaking contrast and not holding pressure.The bdc was removed and the procedure completed using another balloon.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: 23691669
• Report Number: 2024168-2025-11827
• Device Sequence Number: 18735698
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: (01)08717648154621(17)280731(10)50228G1
• 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): 03/20/2026

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: B1050-080
• Device Catalogue Number: B1050-080
• Device Lot Number: 50228G1
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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