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

Model Number	B1120-040
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure performed was to treat a restenosis heavily calcified, heavily tortuous atrioventricular fistula that is 80% stenosed.During the first inflation of a 12x40mm armada 35 balloon dilatation catheter (bdc), a rupture occurred at 6 atmospheres.During removal, the tip did not move and was noted to be separated inside the patient anatomy.A snare was used to remove the separated tip.A new unspecified armada 35 bdc was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in 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 was performed on the returned device.The reported separation was confirmed.The reported balloon rupture was unable to be confirmed due to the condition of the returned device.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 reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture, separation and unexpected medical intervention appear to be related to operational context.In this case, it is likely that the balloon interacted with the heavily calcified anatomy resulting in the reported balloon rupture.The balloon rupture likely did not allow the balloon to refold properly resulting in the material interacting with the patient anatomy and/or accessory device and subsequently lead to the reported separation during removal.Additional treatment with a snare device was performed to remove the separated portion of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 22089508
• Report Number: 2024168-2025-05377
• Device Sequence Number: 15180012
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: (01)08717648154980(17)270531(10)31207G1
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 06/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 31207G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown