MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog 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	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed, moderately calcified, moderately tortuous anterior tibial artery lesion.After crossing the target lesion with a 2.5mm x 120mm armada balloon dilatation catheter (bdc) and a command guide wire, the bdc would only partially inflate when pressurized to nominal pressure.A leak in the hub was noted.Another 3.0mmx120mm armada was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported inflation problem was confirmed.The reported hub leak could not be confirmed; however, a pinhole in the balloon was noted.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.It was reported that the balloon dilation catheter (bdc) only partially inflated due to a hub leak.The returned bdc was attempted to be inflated to nominal pressure.A secure connection with the hub was made; however, the balloon was unable to hold pressure due to a material rupture (pinhole) noted on the balloon.Factors that may contribute to a pinhole on the balloon include, but are not limited to, inadequate balloon integrity, interaction with challenging anatomy, manipulation against resistance, or interaction with accessory devices.Based on the return analysis, and the information provided, it is unknown what may have caused the reported material rupture (pinhole).The pinhole is likely responsible for the inflation problem.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18844994
• Report Number: 2024168-2024-02783
• Device Sequence Number: 12720917
• Product Code: DQY
• UDI-Device Identifier: 08717648156045
• UDI-Public: (01)08717648156045(17)261231(10)3072541
• 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
• Report Date (Section B): 06/19/2024

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 Catalogue Number: A2025-120
• Device Lot Number: 3072541
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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: COMMAND GUIDEWIRE
• Patient Sex: Unknown