MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Armada¿ 35 PTA Catheter; Catheter, Angioplasty, Peripheral, Transluminal

Model Number	B2060-100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 6.0 x 100 mm armada 35 balloon dilatation catheter, when aspirating the balloon air was noted coming into the syringe and a hole was noted in the balloon.There was no patient involvement and no clinically significant delay 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.

• Brand Name: Armada¿ 35 PTA Catheter
• 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--462 ; +1(951)914-5259
• MDR Report Key: 24662951
• Report Number: 2024168-2026-01151
• Device Sequence Number: 15788870
• Product Code: LIT
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: B2060-100
• Device Catalogue Number: B2060-100
• Device Lot Number: 50319G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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 Sex: Unknown