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

Model Number	A1025-040
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
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.
Event or Problem Description
It was reported that the procedure was to treat the left peroneal artery below the knee with no tortuosity, mild calcification and 65% stenosis.When the 2.5x40 mm armada 14 percutaneous transluminal angioplasty (pta) catheter was advanced over the unspecified.014 guide wire, the balloon shaft did not have as much support as usual.Upon removal from the anatomy it was found that the shaft was completely compressed and kinked.Another armada 14 device was used to complete the procedure.There were no patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the inner and outer member were stretched.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported stretched shaft was confirmed.The reported difficulty advancing the device over the guide wire and the material too soft/flexible could not be replicated in a testing environment 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, a definitive cause for the reported difficulty advancing the device over the guide wire could not be determined; however, the reported stretched shaft and material too soft/flexible appear to be related to operational context.Possible factors that may contribute to resistance between the balloon catheter and the guide wire may include, but are not limited to, device placement technique, introducer sheath support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.A conclusive cause for the reported difficulty could not be determined.In this case, it is likely that the shaft of the device became stretched, bunched and kinked during manipulation of the device during attempts to advance it over the guide wire, as difficulty was encountered.Additionally, the caused damage to the shaft gave the impression of not having as much support as usual.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, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22298595
• Report Number: 2024168-2025-06358
• Device Sequence Number: 8594140
• Product Code: LIT
• UDI-Device Identifier: 08717648155734
• UDI-Public: (01)08717648155734(11)240524(17)271031(10)4052441
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Model Number: A1025-040
• Device Catalogue Number: A1025-040
• Device Lot Number: 4052441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .014 GUIDE WIRE
• Patient Sex: Unknown