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

Model Number	A1040-020
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified internal mesenteric artery (ima).A.014 supracore guide wire was placed in the ima.A 3x20mm armada 14 balloon was used to pre-dilated the lesion; however, did not open the lesion enough.The 5.0x18mm herculink stent was attempted to be advanced, but failed to cross due to anatomy.A 4.0x40mm armada 14 balloon was advanced without issue; however, once inflated the balloon ruptured at nominal pressure and removed from the anatomy without issue.A new 4x20mm armada 14 balloon was advanced and once at the target site inflated to nominal pressure; however, ruptured.During removal of the armada 14 balloon resistance was felt with anatomy; however, with gentle tug the device was able to be removed.Under fluoroscopy the distal tip of the balloon was observed on the wire and on removal of the device the tip was noted to remain jailed by the stent.A 3.0x40mm, 4.0x40mm armada 14, other unspecified balloon and with the same 5.0x18mm herculink stent was re-inserted and used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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.The investigation determined the reported complaints appear to be related to operational context.There was no damage noted to the bdc during inspection prior to use or leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Based on the reported information, it is likely that the balloon interaction with the heavily calcified anatomy such that the balloon ruptured during inflation.Additionally, it is likely that the device interacted with the patient¿s challenging anatomy resulting in the reported difficulty removing the device and subsequently as the physician tugged on the device, the device ultimately separated.Additional treatment was performed to remove the departed portion of the device and the tip was noted to remain jailed by the stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional devices referenced in b5 are filed under separate medwatch report numbers.

• 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21537669
• Report Number: 2024168-2025-02366
• Device Sequence Number: 12696672
• Product Code: DQY
• UDI-Device Identifier: 08717648155840
• UDI-Public: (01)08717648155840(17)250531(10)1121541
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102705
• 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
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: A1040-020
• Device Catalogue Number: A1040-020
• Device Lot Number: 1121541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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: Other
• Patient Sex: Unknown