MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013465-150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unspecified coronary artery.The 3.0 x 150 mm armada 18 balloon catheter was advanced in the vessel; however, during the 3rd inflation it was not possible to keep the pressure stable due to a leak at the hub.There was no clinically significant delay in the procedure and no adverse patient effect.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation determined that the reported hub leak appears to be related to a potential product quality issue.The issue is being addressed per internal operation procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9717656
• Report Number: 2024168-2020-01543
• Device Sequence Number: 3220936
• Product Code: LIT
• UDI-Device Identifier: 08717648207914
• UDI-Public: 08717648207914
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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 Expiration Date: 06/30/2020
• Device Model Number: 1013465-150
• Device Catalogue Number: 1013465-150
• Device Lot Number: 7010941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1