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

Model Number	B2060-150
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported kink was confirmed.The reported difficulty advancing and removing the device from the introducer sheath could not be replicated in a testing environment due to the condition of the returned device.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, the investigation determined that the reported complaints appear to be related to circumstances of the procedure.It was reported that the armada 35 catheter was successfully used for pre-dilatation in the anatomy.The armada 35 attempted to be re-advanced in the patient anatomy but encountered resistance with the introducer sheath.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 is likely that the balloon folds became compromised after the first inflation, causing the balloon to not be able to refold properly and/or the device was not held under appropriate vacuum and subsequently resulted in the reported difficulty readvancing and removing the device into the introducer sheath and upon further manipulation the device ultimately kinked.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 procedure was to treat an 80% stenosed lesion in the left superficial femoral artery (sfa) with heavy calcification and mild tortuosity.For pre-dilation, the 6x150mm armada 35 balloon dilatation catheter (bdc) was used without issue; however, after stenting when attempting to reintroduce the bdc for post-dilation, the bdc met with resistance with the 6fr introducer sheath and the shaft of the bdc became kinked.Therefore, the bdc was removed and during removal the bdc met resistance with the introducer sheath.A non-abbott bdc was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported 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 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: 24701652
• Report Number: 2024168-2026-01253
• Device Sequence Number: 21449495
• Product Code: LIT
• UDI-Device Identifier: 08717648155314
• UDI-Public: (01)08717648155314(17)281130(10)50627G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: B2060-150
• Device Catalogue Number: B2060-150
• Device Lot Number: 50627G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .035 GUIDE WIRE; 6FR INTRODUCER SHEATH
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White