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

Model Number	B1050-020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use, leaking was observed during inflation between the inflation port and proximal shaft [hub] on the balloon of the 5.0 x 20 mm armada 35 balloon dilatation catheter.An unspecified device was used to complete the procedure.As it was noted that there was no patient involvement, the leaking will be documented as observed during preparation.There were no reported 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.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported leak was not confirmed.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 reported information and the observations from the returned analysis, a definitive cause for the reported leak could not be determined.In this case, it may be possible that insufficient preparation and/or the sidearm and the syringe (device use for preparation) did not form a secure connection or had a loose connection resulting in the reported leak; however, a conclusive cause cannot be determined since the complaint could not be confirmed during return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: health effect - impact code 4656 removed.
Event or Problem Description
Subsequent to the previously filed report, it was reported that the procedure performed was to treat the superficial femoral artery.During dilatation of the armada 35 bdc in the patient, leaking was observed between the hub and shaft.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis observed the balloon catheter inflated and held pressure.There were no anomalies noted to the device.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 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: 23930250
• Report Number: 2024168-2025-12301
• Device Sequence Number: 21038939
• Product Code: LIT
• UDI-Device Identifier: 08717648154591
• UDI-Public: (01)08717648154591(17)281130(10)50626G1
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/26/2026

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: B1050-020
• Device Catalogue Number: B1050-020
• Device Lot Number: 50626G1
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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