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

Model Number	1013465-150
Medical Device Problem Codes	Leak/Splash (1354); Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported irregular appearance of the refold was confirmed.Additionally, a leak in the sidearm was observed.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 revealed no other complaints.The investigation determined that the leak noted during functional testing of the returned unit appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the armada 18 was successfully inflated at 8 atmospheres in the posterior tibial artery and another distal artery without incident.The armada 18 was removed from the patient and the case continued.The physician was intending to use the armada 18 a third time in the patient when she noticed that the balloon did not appear to have re-wrapped correctly.It was decided to use an armada 35 to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Analysis of the returned device identified a leak.

• 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: 9728251
• Report Number: 2024168-2020-01613
• Device Sequence Number: 2475166
• Product Code: LIT
• UDI-Device Identifier: 08717648207914
• UDI-Public: 08717648207914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/19/2020

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: 02/28/2023
• Device Model Number: 1013465-150
• Device Catalogue Number: 1013465-150
• Device Lot Number: 9092541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1