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

Model Number	1013468-100
Medical Device Problem Codes	Deflation Problem (1149); Failure to Fold (1255); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
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 failure to fold and difficulty advancing the device appear to be related to circumstances of the procedure.It was reported that the armada 18 balloon dilatation catheter (bdc) was initially advanced for pre-dilation successfully; however, experienced deflation issues.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.In this case, a conclusive cause for the reported deflation issue could not be determined since the device was not returned for analysis.Additionally, it is likely that the reported deflation issue contributed to the reported failure to fold the balloon as it is likely that the balloon was not fully deflated and therefore was unable to rewrap properly and subsequently contributed to the reported difficulty re-advancing the device into the sheath for post-dilation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the vessel to be treated was the right popliteal artery.The 300 cm ht command es guide wire was attempted to be advanced through the balloon dilatation catheter port but was unsuccessful and the tip of the guide wire kinked.A new command guide wire was used to continue the procedure.The armada 18 balloon dilatation catheter (bdc) was advanced and inflated once to 8 atmospheres but only partially deflated.Ultimately the balloon was deflated.An attempt was made to use the bdc for post-dilatation, but difficulty was noted advancing the balloon through the introducer sheath.A new armada bdc was used to complete the procedure.There were no adverse patient effects and no clinically significant delay 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: 24491707
• Report Number: 2024168-2026-00859
• Device Sequence Number: 20109980
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: (01)08717648208201(17)290131(10)5081841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/02/2026

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: 1013468-100
• Device Catalogue Number: 1013468-100
• Device Lot Number: 5081841
• 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: 02/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic