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

Model Number	A2025-120
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the tibial artery with moderate calcification and moderate tortuosity.The 2.5x120mm armada 14 balloon dilatation catheter (bdc) was advanced on a command es guidewire (gw) to the target lesion.The balloon was attempted to be inflated multiple times; however, the balloon did not inflate as a leak was noted at the hub of the bdc.Therefore, the bdc was removed from the patient.Another 2.5x120mm armada balloon was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis were performed don the returned device.The reported leak and inflation issue were confirmed.The production record review was performed and revealed no indication of a product quality issue.A review of the complaint history identified no other similar complaints from this lot.The investigation determined a potential product quality issue based on the evaluation of the returned unit and the review of the corrective and preventive actions (capa) database.A leak was observed coming out from the proximal end of the hub.It was determined the device leakage from the proximal end of the luer/hub may possibly be attributed to a gap/channel in the adhesive at the bond area.The investigation determined the noted leak appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 19083288
• Report Number: 2024168-2024-04535
• Device Sequence Number: 8229518
• Product Code: DQY
• UDI-Device Identifier: 08717648156045
• UDI-Public: (01)08717648156045(17)260831(10)3032941
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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 Expiration Date: 08/31/2026
• Device Model Number: A2025-120
• Device Catalogue Number: A2025-120
• Device Lot Number: 3032941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 08/26/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 09/16/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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
• Patient Sex: Unknown