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

Model Number	B2070-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unknown vessel.A 7x40mm armada 35 balloon dilatation catheter (bdc) was attempted to be used during a transcatheter aortic valve replacement (tavr); however a hole in the balloon was noted.Therefore the bdc was replaced with another abbott balloon.There were no adverse patient effects nor clinical delay.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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unknown vessel.A 7x40mm armada 35 balloon dilatation catheter (bdc) was attempted to be used during a transcatheter aortic valve replacement (tavr); however a hole in the balloon was noted.Therefore the bdc was replaced with another abbott balloon.There were no adverse patient effects nor clinical delay.No additional information was provided.Subsequent to the initially reported information, a device was received; however, it can be assumed that the device received was the replacement device used as there were no noted issues found during the product returned analysis.Therefore, the device return status will be updated to not returning.
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 specific issue.Based on the information provided, a definitive cause for the reported balloon rupture could not be determined.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices or patient anatomy.In this case, a conclusive cause for the reported balloon rupture could not be determined since the device was not returned for analysis and limited information was provided.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 correction - device available for evaluation updated from yes to no.

• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21586026
• Report Number: 2024168-2025-02584
• Device Sequence Number: 9276219
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: (01)08717648155352(17)280331(10)41002G1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 04/22/2025

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: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 41002G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• 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 Age: 79 YR
• Patient Sex: Female