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

Model Number	A2025-120
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery with mild calcification.During inflation of the 2.5x120 mm armada 14 percutaneous transluminal angioplasty (pta) catheter to 10 atmospheres, a rupture was noted as the device would not inflate.Another device was used to complete the procedure successfully.There were no adverse patient effects and there was no clinically significant delay in the 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, functional testing, and scanning electron microscopy (sem) analysis were performed on the returned device.The reported inflation issue was confirmed.The reported balloon rupture was not confirmed; however, a leak was noted on the distal end of hub strain relief during return analysis, which is likely what was perceived as the reported rupture, since the balloon would not hold pressure.The production record review was performed and revealed no indication of a product quality issue.The corrective and preventive actions (capa) review was performed and revealed capa issues related to the reported issue; indicating there is a potential product quality issue.Additionally, a review of the complaint history of the reported lot revealed similar complaints from this lot, indicating there is a potential quality issue.The balloon was sent to the sem lab for further analysis.The sem report 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.Radial cross-sections performed just distal and proximal to the bond area revealed possible gaps/channels in the adhesive.The investigation determined a potential product quality issue based on evaluation of the returned unit, the review of the corrective and preventive actions (capa) database and similar complaint review.The leak was observed coming out of the distal end of the stain 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.Additionally, it is likely that the noted leak at the distal end of hub strain relief resulted in the reported inflation issue and the perception of a balloon rupture, since the balloon would not hold pressure.The issue is being addressed per internal operating procedures.Abbott vascular 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: 20386134
• Report Number: 2024168-2024-11797
• Device Sequence Number: 6473184
• Product Code: DQY
• UDI-Device Identifier: 08717648156045
• UDI-Public: (01)08717648156045(17)250930(10)2042641
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• Report Date (Section B): 01/23/2025

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 Expiration Date: 09/30/2025
• Device Model Number: A2025-120
• Device Catalogue Number: A2025-120
• Device Lot Number: 2042641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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