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

Model Number	A2020-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the vessel was mildly tortuosity, moderately calcified and 70% stenosed.The 2.0x200mm armada 14 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion without any resistance.However, during the second inflation to 8 atmospheres the balloon lost pressure.The balloon did not inflate above nominal pressure.An issue with the inflation device was suspected but after the inflation device was changed, the same result was obtained.The armada catheter was removed and was tested on the table, the catheter did not have a leak, it simply did not inflate.A different balloon, brand was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.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.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported balloon rupture was not confirmed; however, a tear was noted on the returned device, which is likely what the account perceived as the reported balloon rupture since the balloon would not hold pressure.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 of the reported lot did not indicate a lot specific quality issue.Based on the reported information and results of the complaint investigation there is no indication the reported balloon rupture or noted tear in the outer member on the returned device is related to a potential product quality issue.There was no leak noted during preparation or during the first inflation, which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis noted a tear on the outer member proximal to the proximal balloon seal.In this case, it is possible that the bdc was inadvertently mishandled during preparation and/or interacted with and accessory device during advancement such that the outer member became damages and upon attempts to inflate the balloon the damaged material leaks, giving the impression of a balloon rupture; however, a conclusive cause cannot be determined.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: 19962140
• Report Number: 2024168-2024-09471
• Device Sequence Number: 8803525
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: (01)08717648155994(17)270331(10)3102341
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 09/30/2024

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: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 3102341
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG