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

Model Number	B2070-080
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a right external iliac artery.Pre-dilatation was performed with a 7x80mm armada 35 balloon dilatation (bdc.Subsequently, a dissection was noted.The bdc possibly contributed to the dissection.Then an unspecified stent was implanted to treat the dissection.Post stent implantation, the bdc was attempted to be re-used.However, the bdc could not advance through the 5f sheath.Therefore, the procedure was completed with another armada bdc device.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported difficulty 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 difficulty advancing the device and unexpected medical intervention appears to be related to circumstances of the procedure.Additionally, a conclusive cause for the reported patient effect of dissection and the relationship to the device, if any, cannot be determined.It was reported that the armada 35 advanced into the lesion and was used for pr-dilatation.A dissection was noted, and additional treatment with an unspecified stent was implanted to treat the dissection.The armada 35 was attempted to be re-used/re-advanced 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 the device into the introducer sheath.The reported patient effect of dissection is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global, instruction for use as a known patient effect.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 24265347
• Report Number: 2024168-2026-00502
• Device Sequence Number: 15957715
• Product Code: LIT
• UDI-Device Identifier: 08717648155376
• UDI-Public: (01)08717648155376(17)290331(10)51001G1
• 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,Followup
• Report Date (Section B): 03/25/2026

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: B2070-080
• Device Catalogue Number: B2070-080
• Device Lot Number: 51001G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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: 5F SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White