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

Model Number	B1120-020
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 received, the investigation determined that the reported balloon rupture appears to be related to operational context.In this case, it was reported that the balloon was inflated to 12 atmospheres.It should be noted that the armada 35 / armada 35 ll instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure (rbp) for this device is 10 atmospheres as indicated on the product label.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.In this case, it is likely that the balloon rupture occurred due to interaction with the moderately calcified anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2017- above rbp.
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, moderately calcified, moderately tortuous iliac artery.Once at the lesion, the 12x20mm armada 35 balloon dilatation catheter (bdc) ruptured at 12 atmospheres during the second inflation.The armada 35 bdc was removed and a non-abbott balloon and unspecified drug-coated balloon were used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21952113
• Report Number: 2024168-2025-04592
• Device Sequence Number: 8720505
• Product Code: LIT
• UDI-Device Identifier: 08717648154973
• UDI-Public: (01)08717648154973(17)270930(10)40403G1
• 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): 05/02/2025

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: B1120-020
• Device Catalogue Number: B1120-020
• Device Lot Number: 40403G1
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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
• Patient Sex: Unknown