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

Model Number	A2025-060
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: medical device problem code 2017 clarifier- use after damage.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and mildly tortuous lesion in the tibial artery.Reportedly a 2.5x60mm on 150cm armada 14 balloon dilatation catheter (bdc), was prepared, however bubbles were noted when a negative pressure was applied.The bdc was still used to dilate the lesion, and following its removal it was noted to have a leak coming from the distal end of the hub.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional and scanning electron microscopy analysis were performed on the returned device.The reported leak was confirmed.The production record review was performed and revealed no indication of a product quality issue.The corrective and preventive actions (capa) review was performed indicating there is a potential product quality issue.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported that the armada 14 balloon dilatation catheter (bdc) was prepared; however, bubbles were noted when a negative pressure was applied.The bdc was still used to dilate the lesion, and following its removal it was noted to have a leak coming from the distal end of the hub.It should be noted that the percutaneous transluminal angioplasty (pta), armada 14, global instructions for use (ifu) specifies: to perform the steps outlined 1 through 7 to remove all air and verify the integrity of the pta catheter.The instructions indicate to perform the steps outside of the patient¿s anatomy and to verify the device preps and does not leak.The device should not be used in the patient anatomy if a leak is noted or suspected.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation determined a potential product quality issue based on the evaluation of the returned unit and the review of the corrective and preventive actions (capa) database.The leak was observed coming out of the distal end of the strain relief tubing.It was determined the device leakage from the distal end of the luer may possibly be attributed to a gap/channel in the adhesive at the distal adhesive bond area.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• 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: 19937443
• Report Number: 2024168-2024-09372
• Device Sequence Number: 12592554
• Product Code: DQY
• UDI-Device Identifier: 08717648156021
• UDI-Public: (01)08717648156021(17)260331(10)2101241
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: 03/31/2026
• Device Model Number: A2025-060
• Device Catalogue Number: A2025-060
• Device Lot Number: 2101241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 75 KG