MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	B1120-040
Medical Device Problem Codes	Unintended System Motion (1430); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
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 provided, a definitive cause for the reported complaints could not be determined.It was reported by the account that the armada 35 balloon dilatation catheter (bdc) was attempted to be advanced into the introducer sheath for a second time.There was no damage noted to the device during inspection prior to use or during the first successful use of the device in the procedure, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it may be possible that the balloon folds became compromised after the first inflation and removal causing difficulty during the attempt to re-insert the device for additional use.Additionally, it was reported that the device kept slipping during use which likely resulted from the patient¿s heavily calcified anatomy; however, this cannot be confirmed.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 a procedure was performed to treat a heavily calcified and tortuous lesion in the common iliac artery.After a non-abbott guidewire was used to cross the lesion, a 12x40mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion; however, it was noted to repeatedly slip during inflation.The aramda bdc was removed and replaced with a 8x20mm bdc and the procedure was continued.However, during an attempt to reinsert the aramda 35 bdc it was noted that the bdc could not be advanced through the 6f sheath.Therefore a new 12x20 armada 35 bdc was used and the procedure was completed.There were no adverse patient effects nor clinical delay.No additional information was provided.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21422714
• Report Number: 2024168-2025-01895
• Device Sequence Number: 12809319
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: (01)08717648154980(17)270531(10)31207G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 31207G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: RADIFOCUS GUIDEWIRE.; SHEATH: 6F 25CM TERUMO.
• Patient Sex: Unknown