MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	1013469-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported balloon rupture could not be confirmed.Production record and corrective and preventative 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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported balloon rupture could not be determined.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices or lesion calcification.In this case, a conclusive cause for the reported balloon rupture could not be determined since the complaint could not be confirmed during return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedureit was reported that the procedure was to treat a lesion in the popliteal artery with mild calcification.The 5.5x40mm armada balloon dilatation catheter (bdc) was advanced to the target lesion without issue.However, when the balloon was inflated to 4 atmospheres (atm), the balloon was losing pressure [material rupture].The balloon was then inflated to 8 atm and the balloon still would not maintain pressure.Therefore, the bdc was removed from the patient, ending the procedure as the patient did not need further treatment.It was noted that an attempt was made to inflate the balloon outside the patient, and a leak was not observed.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.Was to treat a lesion in the popliteal artery with mild calcification.The 5.5x40mm armada balloon dilatation catheter (bdc) was advance to the target lesion and the balloon was inflated to 4 atmospheres (atm) and the balloon was losing pressure.The balloon was then inflated to 8 atm and the balloon still would not maintain pressure.Therefore, the bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
Revised: it was reported that the procedure was to treat a lesion in the popliteal artery with mild calcification.The 5.5x40mm armada balloon dilatation catheter (bdc) was advanced to the target lesion without issue.However, when the balloon was inflated to 4 atmospheres (atm), the balloon was losing pressure [material rupture].The balloon was then inflated to 8 atm and the balloon still would not maintain pressure.Therefore, the bdc was removed from the patient, ending the procedure as the patient did not need further treatment.It was noted that an attempt was made to inflate the balloon outside the patient, and a leak was not observed.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
B5 correction: describe event or problem.

• Brand Name: ARMADA
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 20694372
• Report Number: 2024168-2024-13519
• Device Sequence Number: 12407958
• Product Code: LIT
• UDI-Device Identifier: 08717648208287
• UDI-Public: (01)08717648208287(17)260930(10)3041941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 11/15/2024

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: 09/30/2026
• Device Model Number: 1013469-040
• Device Catalogue Number: 1013469-040
• Device Lot Number: 3041941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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