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

Model Number	A2020-200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
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 the procedure was performed in an unspecified artery.The 2.0x200mm armada 14 balloon dilatation catheter (bdc) was leaking at the valve connection site.Another armada 14 was used to complete the procedure.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional, and scanning electronic microscopy (sem) analysis were performed on the returned device.The reported leak was confirmed.The production record review was performed and revealed no indication of a product quality issue.The corrective and preventive actions (capa) review was performed and revealed capa issues related to the reported issue; indicating there is a potential product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the device leakage at the distal end of the luer may possibly be attributed to a gap/channel in the adhesive at the distal bond area.Radial cross-sections were performed just distal and proximal to the distal adhesive bond area, revealing gaps/channels in the adhesive between the shaft and inner surface of the luer lumen.The investigation determined a potential product quality issue based on the evaluation of the returned unit and the review of the corrective and preventive actions (capa) database.The leak was observed coming out of the distal end of the strain relief tubing.It was determined the device leakage from the distal end of the luer may possibly be attributed to a gap/channel in the adhesive at the distal bond area.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Additional information: d4 - model # added.Corrections: d1 - brand name updated.D2a - common device name updated.D3 - name updated.D3 - address, city, postal code updated.

• 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: 19463930
• Report Number: 2024168-2024-06601
• Device Sequence Number: 6812915
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: (01)08717648155994(17)250630(10)2012441
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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 Expiration Date: 06/30/2025
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 2012441
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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
• Patient Sex: Female