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

Model Number	B2080-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the left common iliac artery with the 8x40mm armada 35 balloon percutaneous transluminal angioplasty catheter.The balloon was inflated once to 10 atmospheres (atm), then a second time to 10atm, when a rupture occurred.Another 8x20mm armada 35 pta and an omni link stent were used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.Based on the reported information, there is no indication that the reported material rupture was related to a product quality issue with respect to the design, manufacture, or labeling of the device.There were no leaks noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, the lesion site was described as heavily calcified.It is likely that balloon material was damaged due to interaction with calcified lesion resulting in material rupture during inflation.

• 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 COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20523123
• Report Number: 2024168-2024-12510
• Device Sequence Number: 9105464
• Product Code: LIT
• UDI-Device Identifier: 08717648155437
• UDI-Public: (01)08717648155437(17)271031(10)40513G1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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
• Report Date (Section B): 10/24/2024

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 Model Number: B2080-040
• Device Catalogue Number: B2080-040
• Device Lot Number: 40513G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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