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

Model Number	B1070-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right common iliac artery (cia) and a chronic total occlusion in the left common iliac artery with heavy calcification.The 7mm armada 18 balloon dilatation catheter (bdc) was used in the procedure; however, the balloon ruptured during the initial inflation at 10 atmospheres (atm).Therefore, the bdc was removed from the patient.A 7x40mm armada 35 balloon dilatation catheter (bdc) was used to continue the procedure.The balloon was inflated to 10 (atm) for 10 seconds without issue.When retracting the balloon back into the introducer sheath, resistance was noted and modest force was applied.The radiopaque marker moved towards the introducer slowly, which led to the operator believing that the balloon was retracting.However, the balloon became elongated and stretched and then broke into two pieces.The armada device was pulled out of the patient with approximately 4/5ths of the balloon still attached to the device.The distal 1/5th along with both radiopaque markers were left inside the patient, still on the non-abbott guide wire (gw).Several attempts were made to remove the remaining balloon parts from the patient including use of lassos and forceps and the proximal radiopaque marker was able to be retrieved; however, the distal marker and the remaining parts of the balloon were attached at the vessel re-entry point could not be removed.The remains of the balloon and the distal radiopaque marker remained in the patient.There was no clinically significant delay reported in the procedure.No additional information was reported.
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 - against resistance.The additional device referenced in b5 is filed under separate medwatch report number.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretching and balloon separation were confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: h6 - code 2017 - against resistance has been removed.

• 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 COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 24393254
• Report Number: 2024168-2026-00700
• Device Sequence Number: 16078334
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782(17)290331(10)51023G2
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K111899
• 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): 03/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 51023G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female