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

Model Number	A1025-200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
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 to treat a lesion in the an peroneal artery with heavy calcification.The 2.5x200mm armada 14 balloon dilatation catheter (bdc) was used in the procedure and the balloon was inflated; however, the balloon pressure began dropping faster than anticipated.A leak at the hub of the bdc was noted.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and canning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported leak was confirmed.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 incidents/complaints from this lot.The balloon was sent to the sem lab for further analysis.The sem report determined the device leakage from the distal end of the luer may possibly be attributed to a channel in the distal bonding area.Radial cross sectioning through the distal bonding area revealed the outer member was positioned on one side of the lumen.Possible leak areas between the outer member/adhesive/luer lumen were documented on the radial cross sections.The investigation determined the leak and noted channel in the distal bonding area of the luer appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Additional Manufacturer Narrative
D1 correction: updated device brand name to align with the information in the corresponding fields in gudid.
Additional Manufacturer Narrative
D4 correction: model number entered.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.

• 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: 18124582
• Report Number: 2024168-2023-12586
• Device Sequence Number: 7753484
• Product Code: DQY
• UDI-Device Identifier: 08717648155772
• UDI-Public: (01)08717648155772(17)251130(10)2061041
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 11/30/2025
• Device Model Number: A1025-200
• Device Catalogue Number: A1025-200
• Device Lot Number: 2061041
• 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: 10/22/2023
• Supplement Date Received by Manufacturer: 02/12/2024; 06/12/2024; 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 03/07/2024; 06/24/2024; 06/24/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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 Age: 68 YR
• Patient Sex: Male