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

Model Number	A2025-200
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo anterior tibial artery.A command es guide wire was advanced to the lesion.Then a 2.5x200mm armada 14 balloon was advanced but when inflated once at 8 atmospheres there was a contrast leak coming from the guide wire port of the device.The armada 14 balloon was removed and replaced with a 2.5x200mm non-abbott balloon to successfully complete the procedure.It was confirmed that the armada balloon was not prepped (air aspiration) outside the anatomy prior to use.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9,h3: device status changed from yes to no.H6: device code 2017 removed.
Additional Manufacturer Narrative
Product performance engineering reviewed the complaint information and analysis of the returned unit.The inflation problem was confirmed.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 balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the inner member leak may be attributed to mechanical damage to the outer surface.The investigation determined, based on the evaluation of the returned unit and sem analysis, that the reported inflation issue was due to a potential quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.D9, h3 - device status changed from not returning to returned.H6 - component code 4755; type of investigation code 4114; investigation findings code 3221 & investigation conclusions code 4315 were removed.
Additional Manufacturer Narrative
Nah10 - qe verbiage updated from "the inflation was confirmed" to "the leak was confirmed.".

• 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: 14417407
• Report Number: 2024168-2022-05288
• Device Sequence Number: 5528135
• Product Code: DQY
• UDI-Device Identifier: 08717648156052
• UDI-Public: 08717648156052
• 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,Followup
• Report Date (Section B): 12/01/2022

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: 06/30/2025
• Device Model Number: A2025-200
• Device Catalogue Number: A2025-200
• Device Lot Number: 2010641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 07/11/2022; 11/21/2022; 12/01/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 07/13/2022; 11/22/2022; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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: COMMAND ES GUIDE WIRE.
• Patient Sex: Unknown