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

Lot Number	40614G1
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in a fistula of the left subclavian with no calcification or tortuosity.A labeled, 12x80x80 mm armada 35 balloon dilatation catheter (bdc) was prepared and advanced into the anatomy; however, when the bdc was inflated it was compared to another 12x60x80mm armada bdc and the balloon measured to be 12x60x80mm which did not match the label on the packaging.The bdc was replaced with another abbott device and the procedure was completed.There were no reported adverse patient effects nor clinical delay.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, functional testing, and dimensional analysis were performed on the returned device.The reported complaint was confirmed.A corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.The production records for this product could not be reviewed and a similar complaint query could not be performed because the part number and lot number were not reported.The investigation determined the reported labeling problem appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D4: the udi number is not known as the part and lot number were not provided.

• 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 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: 21537953
• Report Number: 2024168-2025-02369
• Device Sequence Number: 7857620
• Product Code: LIT
• UDI-Device Identifier: 08717648155000
• UDI-Public: (01)08717648155000(17)271130(10)40614G1
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Lot Number: 40614G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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