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

Model Number	B1120-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left subclavian artery.After a 12x60mm armada 35 balloon dilatation catheter (bdc) was prepared and advanced to the lesion with no reported issues, it was attempted to be used for vessel dilatation; however, the balloon was noted to rupture during the first inflation at approximately 3-4 atmospheres.The ruptured bdc and sheath were removed as a single unit as the balloon had wrapped around the sheath when it ruptured.A new armada was used to complete the procedure.There were no adverse patient effects nor clinical delay.No additional information as 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 review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported balloon rupture could not be determined; however, the reported difficulty removing the device appears to be related to operational context.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, it is likely that the balloon interacted with the patient¿s challenging anatomy such that the balloon became damaged and ruptured; however, since limited information was provided, a conclusive cause cannot be determined.Additionally, the resistance reported during removal likely result from the ruptured balloon material catching on the introducer sheath during removal as the rupture likely did not allow the balloon material to refold properly.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 21375454
• Report Number: 2024168-2025-01635
• Device Sequence Number: 3848881
• Product Code: LIT
• UDI-Device Identifier: 08717648154997
• UDI-Public: (01)08717648154997(17)271130(10)40621G1
• 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): 02/13/2025

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: B1120-060
• Device Catalogue Number: B1120-060
• Device Lot Number: 40621G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 96 KG