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

Model Number	A2015-080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
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 during the procedure, the armada 14 percutaneous transluminal angioplasty (pta) catheter was inflated to 6-8 atmospheres and the tip was noted to break.No parts were missing from the device.There were no reported adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported broken tip was not confirmed; however, the noted indentation on the tip is likely what the account perceived as broken.The production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The investigation was unable to determine a conclusive cause for the reported broken tip or the noted balloon rupture on the returned device.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19927945
• Report Number: 2024168-2024-09327
• Device Sequence Number: 14134506
• Product Code: DQY
• UDI-Device Identifier: 08717648155925
• UDI-Public: (01)08717648155925(17)270131(10)3080341
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/09/2024

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 Model Number: A2015-080
• Device Catalogue Number: A2015-080
• Device Lot Number: 3080341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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