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

Model Number	A2020-120
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
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 the heavily calcified right posterior tibial artery.The 2.0x120 mm armada 14 percutaneous transluminal angioplasty (pta) catheter was prepped according to the instructions for use (ifu) and was advanced to the lesion and inflated to nominal pressure.It was noted that the device was not holding pressure but it was holding contrast and there was a leak of fluid outside the anatomy at the hub of the device.Therefore, the device was removed and a 2.0x100 armada 14 pta catheter was used to complete the procedure.The same indeflator was used with both balloons.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional and scanning electron microscopy inspection/analysis were performed on the returned device.The reported leak was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined a potential product quality issue based on the reported leak and noted channel in the distal adhesive bonding area.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Additional Manufacturer Narrative
H2 correction: updated the device identification fields to align with the information in the corresponding fields in gudid.Visual, functional and sem inspections/analysis were performed on the returned device.The reported leak was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined a potential product quality issue based on the reported leak and noted channel in the distal adhesive bonding area.

• 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: 18016407
• Report Number: 2024168-2023-11902
• Device Sequence Number: 6537668
• Product Code: DQY
• UDI-Device Identifier: 08717648155987
• UDI-Public: (01)08717648155987(17)251130(10)2062941
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 11/30/2025
• Device Model Number: A2020-120
• Device Catalogue Number: A2020-120
• Device Lot Number: 2062941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/08/2023; 06/12/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/27/2023; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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: INDEFLATOR.
• Patient Sex: Female