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

Model Number	1013470-060
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 information provided, a definitive cause for the reported deflation issue could not be determined; however, the reported difficulty removing the device, separation and unexpected medical intervention appear to be related to circumstances of the procedure.In this case, since the contrast ratio used was less than the required percentage, it is unknown if the instructions for use (ifu) violation caused or contributed to the reported complaint.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, manufacturing, deflation technique, loose connection with the indeflator, contrast concentration, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.It was reported by the account that there was resistance during removal.In this case, it is likely that since the balloon was unable to completely deflate, it interacted with the patient anatomy and/or accessory device, resulted in the reported resistance and subsequently the balloon separated, as difficulty was encountered.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: device code 2017 - improper or incorrect procedure or method - contrast incorrect.
Event or Problem Description
It was reported that the procedure was to treat in stent restenosis in the superficial femoral artery (sfa).The 6x60mm armada 18 balloon dilation catheter (bdc) was used in the procedure with a 1/3 contrast to 2/3 saline ratio.Post balloon dilatation, the balloon was only able to be partially deflated and during removal of the bdc resistance was noted; therefore, a 20cc syringe was used to withdraw air from the balloon.When the bdc was outside the patient the balloon was noted to have become separated from the delivery catheter.Therefore, a snare was used to retrieve the separated balloon.There was no adverse patient sequela and no clinically significant delay reported in the procedure.No additional information was provided.

• 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: 22203345
• Report Number: 2024168-2025-06122
• Device Sequence Number: 20750115
• Product Code: LIT
• UDI-Device Identifier: 08717648208409
• UDI-Public: (01)08717648208409(17)280731(10)5020441
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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
• Report Date (Section B): 06/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1013470-060
• Device Catalogue Number: 1014254-180
• Device Lot Number: 5020441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown