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

Model Number	B1050-040
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
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.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 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 unknown if the violation of the instructions for use (ifu) caused or contributed to the reported complaint.Based on the information provided, a definitive cause for the reported complaints could not be determined.In this case, it is unknown if the violation of the instructions for use (ifu) caused or contributed to the reported complaint.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices or patient anatomy.In this case, a conclusive cause for the reported balloon rupture could not be determined since the device was not returned for analysis.Additionally, it¿s possible that the balloon experienced inflation issues as a result of the balloon rupture; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - incorrect prep.
Event or Problem Description
It was reported that during the hemodialysis access dilation surgery the 5.0x40mm armada 35 balloon dilatation catheter (bdc) was advanced into the patient anatomy and when the device was purged, small bubbles were noted.When the balloon was inflated three times to 8 atmospheres, the balloon filled unevenly and contained many small bubbles; which led the physician to make a poor judgment on the effectiveness of the surgical dilation.Another armada 35 bdc was used to complete the procedure.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: 23451461
• Report Number: 2024168-2025-11301
• Device Sequence Number: 8073746
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: (01)08717648154607(17)280630(10)50131G1
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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 Model Number: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 50131G1
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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