MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1080-060
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 8x60mm armada 35 balloon catheter, the hub was noted to be cracked/broken.Therefore, the device was not used in the patient.Another armada was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a leak of fluid out of the cracks in the hub on functional testing.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported break crack was confirmed.Additionally on functional testing, fluid came out of the noted cracks in the hub.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18518704
• Report Number: 2024168-2024-00871
• Device Sequence Number: 20516310
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/16/2024

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 Catalogue Number: B1080-060
• Device Lot Number: 30727G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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