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

Model Number	1013468-200
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that procedure performed was to treat a moderately calcified lesion in the superficial femoral artery.After successful use of the 5.0x200mm armada 18 balloon dilatation catheter (bdc), the armada 18 bdc was used a second time; however, the balloon failed to fold properly and could not re-enter the introducer sheath.An unspecified balloon was used to complete the procedure.There were no adverse patient effects and no clinically significant delays 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.H6 medical device problem code: 2017 - contrast incorrect.
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 complaints could not be determined.There was no damage noted to the device during inspection prior to use or during the first successful advancement of the device in the procedure, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it may be possible that the balloon folds became compromised after the first inflation, causing the balloon to not be able to refold properly and subsequently resulting in the reported difficulty re-inserting the device into the introducer sheath and attempting to readvance the device into the sheath; however, a conclusive cause cannot be determined since the device and component were not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.E1 correction: physician's name.H6: additional medical device problem code.
Event or Problem Description
Subsequent to the initial filed report, the 5.0x200mm armada 18 balloon dilatation catheter (bdc) was advanced to the lesion.After the second inflation, the balloon failed to fold properly.During removal, the balloon had difficulty exiting the introducer sheath.After removal, another attempt was made to advance the bdc but resistance was met with the introducer sheath.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: 23946884
• Report Number: 2024168-2026-00037
• Device Sequence Number: 7845417
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: (01)08717648208249(17)290228(10)5092341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/19/2026

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: 1013468-200
• Device Catalogue Number: 1013468-200
• Device Lot Number: 5092341
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Hispanic
• Patient Race: White