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

Model Number	B2070-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was an endovascular abdominal aortic aneurysm repair (evar) and renal stenting.The 7x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion with resistance noted with the anatomy.The balloon ruptured after 4-5 inflations and deflations to nominal pressure and ruptured at 6 atmospheres.There was resistance with the anatomy during removal.The balloon catheter snapped into two pieces and a portion remained in the patient anatomy.Thirty minutes was spent to retrieve the separated piece with a snare.There were no adverse patient sequela.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 was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty advancing and removing the device from the anatomy could not be replicated in a testing environment as they were based on operational circumstances.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture, separation, difficulty advancing and removing the device and unexpected medical intervention appear to be related to operational context.There was no leak noted to the balloon during preparation or during the initial 4-5 inflations, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the armada 35 device interacted with the patient¿s challenging anatomy resulting in the reported difficulty advancing the device and subsequently the balloon ruptured during inflation.In addition, the ruptured balloon material likely interacted with the patient¿s anatomy during removal, resulting in the reported difficulty removing the device and upon further manipulation, the balloon and inner member ultimately separated.Additional treatment with a snare device was performed to remove the separated portion of the device.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: 22122586
• Report Number: 2024168-2025-05576
• Device Sequence Number: 4170906
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: (01)08717648155352(17)270331(10)31003G1
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 06/18/2025

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: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 31003G1
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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