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

Model Number	B1080-040
Medical Device Problem Codes	Material Rupture (1546); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The 8x40mm armada balloon dilatation catheter (bdc) was returned for analysis with another reported device.The device analysis noted a rupture on the balloon.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.B3, b6: dates estimated.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The returned device analysis noted a longitudinal balloon rupture.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 noted 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 limited information was provided.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: 20798796
• Report Number: 2024168-2024-14012
• Device Sequence Number: 6833111
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: (01)08717648154867(17)270731(10)40226G3
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: B1080-040
• Device Catalogue Number: B1080-040
• Device Lot Number: 40226G3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: Unknown