MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA¿; CATHETER, PERCUTANEOUS

Model Number	B2070-120
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported balloon rupture, difficulty removing the device, separation and unexpected medial intervention appear to be related to operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the previously implanted stent such that the balloon became damaged and subsequently ruptured during inflation.Additionally, it is likely that the ruptured balloon material became stuck on the patient¿s anatomy and/or accessory devices, resulting in the reported difficulty removing the device and subsequently the device ultimately separated during removal.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 the procedure was to treat in-stent restenosis in the left superficial femoral artery.The 7.0 x 120 mm armada 35 balloon dilatation catheter was advanced to the target lesion however during the first inflation the balloon ruptured at 10 atmospheres.The balloon was deflated as much as possible however during removal resistance was met and the catheter shaft separated.A snare device was used to retrieve the separated portion.No additional information was provided.

• Brand Name: ARMADA¿
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 25315324
• Report Number: 2024168-2026-02162
• Device Sequence Number: 9938390
• Product Code: DQY
• UDI-Device Identifier: 08717648155390
• UDI-Public: (01)08717648155390(17)290228(10)50903G1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/28/2026

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: B2070-120
• Device Catalogue Number: B2070-120
• Device Lot Number: 50903G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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: Unknown