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

Model Number	A2020-200
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and investigated.The inflation problem was confirmed.Additionally, the proximal portion of the balloon ruptured and tore through the proximal seal and outer member.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific issue.The investigation determined, based on the evaluation of the returned unit and scanning electron microscopy (sem) analysis, that the reported inflation issue may be due to a potential quality issue.The damage to the balloon and necked outer member may be related to a manufacturing issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported the procedure was performed to treat a lesion located in the anterior tibial artery.The armada balloon was inserted and was advanced to the target lesion without difficulty; however, the balloon was unable to inflate or may have been able to inflate, and hold pressure, but the inflation was incomplete.The device was removed without issue.There was no adverse patient effect and no clinically significant delay in the procedure.A non-abbott device was used to complete the procedure.No additional information was provided.Device analysis on 7/7/2022 indicated a material rupture (longitudinal, balloon, proximal seal and outer member) of the proximal portion of the balloon.

• 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: 15107616
• Report Number: 2024168-2022-08186
• Device Sequence Number: 4149792
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: 08717648155994
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 07/26/2022

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: 04/30/2025
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 1110441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Unknown