MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	A2030-120
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
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: 1494 device code clarifier- incorrect anatomy.
Event or Problem Description
It was reported that the procedure was treat a mildly calcified, mildly tortuous left internal carotid artery that is 90% stenosed.A viatrac carotid balloon was not available; therefore, the 3.0x120mm armada 14 balloon catheter was inflated to 8 atmospheres; however, would not inflate.The device was losing pressure when attempting to inflate.The pressure was released to pull back the pressure pump.Blood was found to flow back the pressure pump.Another armada 14 was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported that the procedure was to treat a left internal carotid artery.It should be noted that the percutaneous transluminal angioplasty (pta), armada 14, global instructions for use (ifu) states: the device is indicated to dilate stenosis in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.In this case, it is unknown if the ifu violation caused or contributed to the reported compliant.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
D4 correction: model number entered.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.
Additional Manufacturer Narrative
D1 correction: updated device brand name to align with the information in the corresponding fields in gudid.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17873760
• Report Number: 2024168-2023-10878
• Device Sequence Number: 7381460
• Product Code: DQY
• UDI-Device Identifier: 08717648156106
• UDI-Public: (01)08717648156106(17)251231(10)2070841
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102705
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 12/31/2025
• Device Model Number: A2030-120
• Device Catalogue Number: A2030-120
• Device Lot Number: 2070841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/13/2023; 06/12/2024; 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/04/2023; 06/24/2024; 06/24/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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